JP7520733B2 - Tissue removal system and method - Google Patents

Description

The present invention relates to medical devices, and in particular to systems and methods for retrieval or removal of tissue from a body orifice.

Description of Related Applications
This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62/079,171, entitled "Systems and methods for tissue removal," filed November 13, 2014, U.S. Provisional Patent Application No. 62/081,297, entitled "Systems and methods for tissue removal," filed November 18, 2014, and U.S. Provisional Patent Application No. 62/107,107, entitled "Cut-resistant retracting tissue bag," filed January 23, 2015.

Systems and methods for surgical removal of tissue from small incision sites and/or body orifices, including various body orifices, have been described. When necessary, a small incision is made in the patient to access the surgically targeted tissue located within the body cavity. The surgically targeted tissue may also be accessed through the orifice without making an initial incision. In some cases, the target tissue is accessed directly through the incision or orifice. In some cases, an access instrument system is placed and positioned in, across, at and/or within the incision and/or orifice to retract, enlarge, reshape and/or isolate the tissue from the incision or orifice. The access instrument system acts as a gate or portal to access the target tissue located within or adjacent to the body cavity or orifice. The target tissue is dissected from adjacent and surrounding tissue employing known surgical techniques or procedures. Once freed, the target tissue is ready for removal through the small incision or orifice. When the target tissue is too large to remove in its entirety, the size of the target tissue is reduced and portions of the target tissue are removed through small incisions. Ideally, the surgeon will "core" or "peel" the target tissue to keep it as whole as possible; however, more than half of the time, the target tissue will end up in many small pieces.

Reducing the size of the target tissue is called morcellation. Morcellation involves cutting the target tissue into small pieces using a scalpel or knife, either manually or by employing a powered morcellator, and cutting the target tissue so that it can be removed through a small incision. The small pieces of target tissue are removed from the patient through the small incision. When reducing the size of the target tissue to pass through the small incision, small pieces of tissue may be cut off and left inside the patient. Morcellation is therefore contraindicated in cases of malignant tumors or endometriosis. If the cancer is morcellated, such morcellation may lead to the spread of malignant tissue, upstaging the cancer, and increased mortality in the patient.

Hysterectomy is one example of a surgical procedure that may involve morcellation. Over 500,000 hysterectomies are performed annually on women in the United States. The usual reasons why a woman may undergo a hysterectomy are if she has fibroids, cancer, endometriosis, or uterine prolapse. Approximately 200,000 of these hysterectomies are performed laparoscopically. If the uterus is too large (over 300 g) to be removed through the vagina or if the cervix is still in place, the specimen must be reduced in size for removal through an abdominal incision or through the vagina. During myomectomy (fibroid removal), it may be necessary to remove large fibroids using a morcellation technique. During morcellation, the target tissue (usually the uterus and possibly adnexal structures) is brought to the abdominal wall surface, for example by a tissue grasper, reduced in size with a blade, and removed from the pelvic cavity through the incision. Alternatively, the target tissue is removed through a body orifice, for example the vagina. Fibroids or uterine leiomyomas are responsible for approximately 30-40% of hysterectomies. These are benign tumors of the uterus that can lead to heavy and painful bleeding. In the past, these tumors may be missed cancers or leiomyomas, and were thought to affect approximately 1 in 10,000 women. More recent data supports the extremely high risk of missed malignancies among these tumors, estimated to range from 1:1000 to 1:400. Because of this high risk, many surgeons have begun to change their techniques to perform a closed morcellation process, encasing the specimen by morcellating in a pouch to contain the stray pieces and prevent the spread and seeding of tumor cells, rather than performing the morcellation without a pouch in a process called open morcellation. Many GYN societies, including AAGL, ACOG, and SGO, have issued statements warning of the potential dangers of open morcellation. On April 17, 2014, the FDA issued a statement discouraging the use of open power morcellation for the performance of hysterectomies and myomectomies for women undergoing these procedures for fibroids. The FDA has also increased the estimated likelihood of malignancy to 1 in 350. For these reasons, there is a need for systems and methods that safely and effectively reduce tissue specimens. The present invention relates to such safe systems and methods for both manual and power morcellation performed in a closed system.

According to one aspect of the invention, a system for removing a tissue specimen through a body opening that defines a tissue margin is provided. The system includes a shield. The shield has a band made of a soft, cut-resistant material. The band has inner and outer surfaces connected to each other by top and bottom ends and first and second ends. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that the band can move to a reduced configuration in which at least a portion of the outer surface at the first end overlaps with the inner surface at the second end and forms a spiral in juxtaposition with the inner surface and constitutes an overlapping portion. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed on the inner surface. The inner abutment extends along at least a portion of the band along the longitudinal axis between the top and bottom ends. The first end is configured to contact the inner abutment to prevent reduction in the inner diameter in the locked configuration.

According to another aspect of the invention, a system for removing a tissue specimen through a body opening that defines a tissue margin is provided. The system includes a shield. The shield has a band made of a soft cut-resistant material. The band has an inner surface and an outer surface connected to each other by a top end and a bottom end and a first end and a second end. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that the band can move to a reduced configuration in which at least a portion of the outer surface at the first end overlaps with the inner surface at the second end and forms a spiral in juxtaposition with the inner surface and constitutes an overlapping portion. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed on the inner surface and at least one outer abutment formed on the outer surface. The inner abutment and the outer abutment extend along at least a portion of the band along the longitudinal axis between the top and bottom ends. The at least one inner abutment is configured to contact the at least one outer abutment to prevent reduction of the inner diameter in the locked configuration.

According to another aspect of the invention, a system for removing a tissue specimen through a body opening that defines a tissue margin is provided. The system includes a shield. The shield has a band made of a soft cut-resistant material. The band has an inner surface and an outer surface connected to each other by a top end and a bottom end and a first end and a second end. The band is configured to define a central lumen with a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The band is segmented such that the band can move to a reduced configuration in which at least a portion of the outer surface at the first end overlaps with the inner surface at the second end and is in juxtaposition with the inner surface to form a spiral and constitute an overlapping portion. The shield is configured to have a variable lumen diameter by varying the overlapping portion. The shield includes a locking mechanism configured to fix the lumen diameter. The locking mechanism includes at least one inner abutment formed within the inner surface. The at least one inner abutment is configured to contact one of the at least one outer abutment formed in the first end or the outer surface to define a locked configuration having a locked lumen diameter.

1 is a cross-sectional view of a containment bag and guard according to the present invention positioned within an opening in a body wall. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is an end view of a guard according to the present invention. 5 is a cross-sectional view of the guard according to the present invention taken along line 5-5 of FIG. 4; 6 is a cross-sectional view of the guard according to the present invention taken along line 6-6 of FIG. 4; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is an end view of a guard according to the present invention. 10 is a cross-sectional view of the guard according to the present invention taken along line 10-10 of FIG. 9; FIG. 2 is a top perspective view of a cap according to the present invention. FIG. 2 is a cross-sectional side view of a cap and guard according to the present invention. FIG. 2 is a side view of a cap and guard according to the present invention. FIG. 2 is a top perspective view of a cap and guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; 1 is a cross-sectional side view of a guard according to the present invention; FIG. 1 is a top perspective view of a retractor according to the present invention. FIG. 1 is a top perspective view of a retractor according to the present invention. FIG. 2 is a top perspective view of a containment bag and retractor combination according to the present invention. FIG. 2 is a cross-sectional side view of a containment bag with a tissue specimen, a body wall and two rings in accordance with the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention in an expanded state. FIG. 2 is a top perspective view of a containment bag according to the present invention in a partially collapsed state. FIG. 2 is a top perspective view of a containment bag according to the present invention in a twisted state. FIG. 2 is a plan view of a containment bag according to the present invention in a twisted state. FIG. 2 is a top perspective view of a two-piece guard according to the present invention in an unassembled state. FIG. 2 is a top perspective view of an assembled two-piece guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a retractor ring and guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; 1 is a partial cross-sectional view of a retractor ring and guard according to the present invention. FIG. 1 is a top perspective view of a balloon trocar with a removable seal housing according to the present invention. 1 is a cross-sectional side view of a balloon trocar according to the present invention. FIG. 2 is a side view of a ballast according to the present invention. FIG. 2 is a bottom view of a ballast according to the present invention. 34 is a cross-sectional view of the ballast according to the present invention taken along line 34-34 of FIG. 33. FIG. 2 is a side view of a mortar stabilizer according to the present invention. FIG. 2 is a cross-sectional plan view of a morsel stabilizer in a locked configuration in accordance with the present invention; FIG. 2 is a top view of a ballast according to the present invention in an unlocked configuration. FIG. 2 is a cross-sectional plan view of a mortar stabilizer in an unlocked configuration in accordance with the present invention; FIG. 2 is a top perspective view of a containment bag positioned within a body opening in accordance with the present invention. FIG. 2 is a top perspective view of a containment bag positioned within a body orifice and a morcellator stabilizer coupled to the containment bag in an unlocked configuration in accordance with the present invention. FIG. 1 is a top perspective view of a morcellator having a protective obturator connected to a stabilizing cap in accordance with the present invention. FIG. 1 is a bottom perspective view of a morcellator having a protective obturator connected to a stabilizing cap in accordance with the present invention. FIG. 2 is a top perspective view of a morcellator coupled to a stabilizing cap in accordance with the present invention. FIG. 2 is a top perspective view of a stabilizing cap according to the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; 1 is a cross-sectional side view of a tissue specimen within a containment bag positioned across a body wall in accordance with the present invention. FIG. 2 is a side view of a containment bag deployment device according to the present invention. FIG. 2 is a side view of a containment bag and deployment cap according to the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; 1 is a cross-sectional side view of a tissue specimen within a containment bag positioned across a body wall in accordance with the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 2 is a plan view of a storage bag according to the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 2 is a plan view of a pattern for a containment bag according to the present invention, in which solid lines indicate valley folds and dashed lines indicate angle folds. FIG. 2 is a partial plan view of a pattern with dimensions for a containment bag according to the present invention. FIG. 2 is a plan view of a pattern for a containment bag that is substantially square when viewed from above in accordance with the present invention. FIG. 2 is a plan view of a containment bag with a triangular open end in accordance with the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard in a mold according to the present invention. FIG. 2 is a top perspective view of a guard on a mold according to the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 2 is a side view of a ring of a containment bag according to the present invention. 55B-55B is a cross-sectional view of the ring of the containment bag according to the present invention taken along line 55B-55B in FIG. 55A. FIG. 2 is a top perspective view of a semi-rigid rod before being formed into a ring for a containment bag according to the present invention. FIG. 2 is a top perspective view of a ring of a containment bag according to the present invention; FIG. 2 is a plan view of a side wall of a containment bag according to the present invention. FIG. 2 is a side view of a side wall of a containment bag according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. 5 is a cross-sectional view of the storage bag 58A taken along line 58B according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. FIG. 2 is a top perspective view of a containment bag according to the present invention; FIG. 1 is a top perspective view of a bag introducer according to the present invention. FIG. 1 is a top perspective view of a bag introducer according to the present invention. FIG. 2 is a top perspective view of a containment bag and bag introducer according to the present invention. FIG. 2 is a top perspective view of a containment bag and bag introducer according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; 1 is a cross-sectional side view of a tissue specimen within a containment bag and guard positioned across a body wall in accordance with the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of two side wall components of a guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a side view of a guard in a body opening according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a partial perspective side view of a guard according to the present invention. FIG. 2 is a partial perspective side view of a guard according to the present invention. 1 is a cross-sectional view of a side wall of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a semi-transparent bottom view of a guard according to the present invention. FIG. 2 is a semi-transparent plan view of a guard according to the present invention. A cross-sectional view of the guard according to the present invention taken along line 78C-78C of FIG. 78B. FIG. 2 is a top perspective partial see-through view of a guard according to the present invention; FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a cross-sectional plan view of a guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a side view of a morcellator and guard according to the present invention. FIG. 2 is a cross-sectional side view of a morcellator and guard according to the present invention. FIG. 2 is a bottom perspective view of the morcellator according to the present invention; FIG. 1 is a top perspective view of an energy morcellator and grasper according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective partial see-through view of a guard according to the present invention; FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a partial perspective side view of a guard according to the present invention. FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a partial perspective plan view of a guard according to the present invention; FIG. 2 is a cross-sectional plan view of a guard according to the present invention. FIG. 2 is a partially cutaway perspective plan view of a guard according to the present invention; FIG. 2 is a partial perspective side view of a retractor and guard according to the present invention. FIG. 2 is a cross-sectional side view of a retractor and guard according to the present invention. FIG. 2 is a cross-sectional top perspective view of a retractor and guard according to the present invention. FIG. 2 is a cross-sectional top perspective view of a retractor and guard according to the present invention. FIG. 2 is a top, partially transparent perspective view of a retractor and guard according to the present invention. FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a top perspective view of a retractor and guard according to the present invention. FIG. 2 is a top view of a retractor and guard according to the present invention. FIG. 2 is a bottom perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a bottom perspective view of a guard according to the present invention; FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a bottom perspective view of a guard according to the present invention; FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a top perspective view of a guard according to the present invention; FIG. 2 is a top perspective view of a two-piece guard according to the present invention; FIG. 2 is a top perspective view of a blade guard according to the present invention; FIG. 2 is a cross-sectional top perspective view of a blade guard according to the present invention; 2 is a cross-sectional view of a blade receiver of the blade guard according to the present invention; FIG. 2 is a bottom perspective view of a blade according to the present invention; FIG. 1 is a top perspective view of a blade according to the present invention; FIG. 2 is an exploded top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. 2 is an exploded top perspective view of a blade guard assembly according to the present invention; FIG. 2 is an exploded top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a bottom view of a blade guard assembly according to the present invention. FIG. 2 is a cross-sectional top perspective view of a blade guard assembly according to the present invention; FIG. 2 is a bottom perspective view of a blade guard assembly according to the present invention; FIG. 2 is a side view of a containment bag according to the present invention. FIG. 1 is a top perspective view of a tissue grasper and morcellator according to the present invention. 1 is a cross-sectional side view of a handle of a tissue grasper according to the present invention. 1 is a cross-sectional side view of a distal end of a tissue grasper according to the present invention. FIG. 2 is a cross-sectional top perspective view of the distal end of a tissue grasper according to the present invention. 1 is a cross-sectional side view of a distal end of a tissue grasper according to the present invention. FIG. 1 is a top perspective view of a morcellator according to the present invention. FIG. 2 is a bottom perspective view of the morcellator according to the present invention; FIG. 2 is a side view of a containment bag according to the present invention. FIG. 2 is a plan view of a containment bag according to the present invention in a rolled up configuration; FIG. 2 is an end view of a containment bag according to the present invention in a rolled up configuration. FIG. 2 is an end view of a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. FIG. 2 is a plan view of a containment bag according to the present invention in an open state. 1 is a cross-sectional view of a ring of a containment bag according to the present invention; 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard rolled around a bag ring according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. FIG. 2 is a plan view of a containment bag according to the present invention in an open state. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. FIG. 2 is a plan view of a storage bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and tissue guard according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. 142B-142B is a cross-sectional view of the storage bag according to the present invention taken along line 142B-142B in FIG. 142A. 1 is a cross-sectional view of a containment bag in an inflated state according to the present invention; 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag and tissue guard according to the present invention. FIG. 2 is a side view of a containment bag according to the present invention. 144B-144B is a cross-sectional view of the storage bag according to the present invention taken along line 144B-144B in FIG. 144A. 1 is a cross-sectional view of a containment bag in an inflated state according to the present invention; 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag pulled upwardly in accordance with the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within an inflated containment bag and tissue guard according to the present invention. FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a bottom view of the guard according to the present invention. FIG. 2 is a plan view of a guard according to the present invention. FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a side view of a guard according to the present invention. FIG. 2 is a plan view of a guard according to the present invention. FIG. 1 is a top perspective view of a shred and bag system according to the present invention. FIG. 1 is a top perspective view of a motorized morcellator according to the present invention; FIG. 1 is a cross-sectional top perspective view of a motorized morcellator according to the present invention; 1 is a cross-sectional view of a powered morcellator according to the present invention; 1 is a cross-sectional view of a powered morcellator according to the present invention; 1 is a top perspective view of a specimen container according to the present invention; FIG. FIG. 2 is a cross-sectional top perspective view of a bag tube and bag according to the present invention. FIG. 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; FIG. 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; FIG. 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; FIG. 2 is a cross-sectional top perspective view of a gripper and containment bag according to the present invention in an open configuration; FIG. 2 is a cross-sectional top perspective view of a containment bag wrapped around a gripper in accordance with the present invention. FIG. 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; FIG. 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in an open configuration; 1 is a cross-sectional perspective view from above of a containment bag according to the present invention in a closed configuration; FIG. 2 is a plan view of a guard according to the present invention. FIG. 13 is a side view of a guard attached to a morcellator shaft according to the present invention. FIG. 1 is a top view of a guard attached to a morcellator shaft in accordance with the present invention. FIG. 13 is a cross-sectional side view of a guard and containment bag attached to a morcellator shaft in accordance with the present invention. FIG. 13 is a cross-sectional plan view of a guard attached to a morcellator shaft in accordance with the present invention. FIG. 13 is a cross-sectional side view of a guard attached to a morcellator shaft in accordance with the present invention. FIG. 2 is a cross-sectional top perspective view of a containment bag with a bag tube and a top opening according to the present invention. FIG. 2 is a cross-sectional side view of a containment bag with a bag tube and a side opening according to the present invention. FIG. 2 is a cross-sectional side view of a containment bag with a bag tube and a side opening according to the present invention. FIG. 2 is a side view of a tissue specimen in a containment bag according to the present invention. FIG. 1 is a cross-sectional side view of a tissue specimen within a containment bag attached to a morcellator in accordance with the present invention. FIG. 2 is a plan view of a containment bag attached to a morcellator according to the present invention. FIG. 2 is a cross-sectional side view of a containment bag and morcellator system according to the present invention. 1 is a cross-sectional side view of a body wall, a tissue specimen, and a containment bag and morcellator system according to the present invention. 1 is a cross-sectional side view of a body wall and a tissue specimen within a containment bag and morcellator system according to the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a plan view of the shield of the present invention. FIG. 2 is a top partial cross-sectional plan view of a shield in a locked configuration in accordance with the present invention. FIG. 2 is a bottom perspective view of the shield of the present invention; FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a plan view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a partial plan view of a shield of the present invention. FIG. 2 is a partial cross-sectional plan view of a shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention. FIG. 2 is a partial top perspective view of the shield of the present invention. FIG. 2 is a top perspective view of the shield of the present invention.

The following description is provided to enable one skilled in the art to make and use the surgical tools and practice the methods described herein, and relates to the best mode contemplated by the inventor for practicing his invention. However, various modifications will remain apparent to those skilled in the art. These modifications are contemplated to be within the scope of the invention. It may be said that different embodiments or aspects of such embodiments are shown in the various figures and described throughout the specification. However, it should be noted that although separately shown or described, each embodiment and its various aspects can be combined with one or more of the other embodiments and their various aspects, unless otherwise specified. Each combination has not been explicitly described solely to ensure readability of the specification.

1, a closed morcellation procedure of the present invention is shown. A small incision is made in the patient at the location of the abdominal wall 10 and the body cavity 12 is accessed through an opening 14 across the abdominal wall 10. Using laparoscopic techniques and instruments, such as trocars, laparoscopes, graspers and scalpels, a single site opening can be made, the target tissue can be explored and the target tissue can be dissected from surrounding tissue structures. Additional incisions or access sites can be used to insert instruments and scopes to facilitate the performance of the morcellation procedure. The target tissue 16, such as at least a portion of the uterus in a hysterectomy procedure, is completely dissected and a specimen retrieval bag 18 is inserted through the opening 14 in the abdominal wall 10 and positioned within the body cavity 12. The bag 18 can be passed through a trocar or cannula positioned across the abdominal wall 10. The bag 18 is unfolded and oriented within the body cavity 12. The target tissue 16 is placed into the bag 18 through an opening 20 in the bag 18. Various types of bags 18 can be used. The bag 18 can be transparent so that the contents can be viewed from outside the bag 18 with a scope placed in the body cavity 12 through a secondary incision site made across the abdominal wall 10. The contents of the bag 18 can be illuminated from outside the bag 18. The location of the target tissue 16 can also be viewed through the transparent bag 18 to ascertain the progress of morcellation and the location and proximity of the target tissue 16 to the opening 14. The secondary site insertion method can also be used to view the bag 18 to ensure that it is not tangled or twisted and to bring the specimen closer to the opening, thereby not pulling the bag 18 with the specimen, which could result in the bag accidentally coming into contact with the blade and being cut. Alternatively, an opaque bag 18 can be used. The material of the bag 18 is also important. Generally speaking, when made of plastic, the bag is strong enough to withstand pulling and reeling, has sufficient scratch resistance, yet is relatively thin and flexible, and is resistant to puncture and tearing. The bag can be folded to reduce its size so that it can be inserted through a small incision/trocar of at least about 5 mm in diameter. Also, when opened, the bag is large enough to accommodate a large piece of tissue and extend through the opening 14 to the surface of the abdominal wall 10, and create a large enough working space within the bag 18 for the instruments, scope, morcellator 24, and scalpel 26 as shown in FIG. 1. The bag 18 has a tether or drawstring 22 configured to pull the opening closed and open the bag 18. The bag 18 can withstand inflation pressure without leaking. Various examples of bags and devices for inserting, deploying and/or retrieving the bags to be provided or integrated into a morcellation system configured such that the entire system, portions of the system or a combination of the system and/or its components can accommodate an object to be morcellated in accordance with various embodiments of the present invention are described in U.S. Patent Application Nos. 08/540,795, filed October 11, 1995; 11/549,701, filed October 16, 2006; 11/549,971, filed October 16, 2006; 12/902,055, filed October 11, 2010; and 13/252,110, filed October 3, 2011, which are incorporated by reference and are incorporated herein in their entireties as if fully set forth herein. Additional bag variations are described in detail below.

After the target tissue 16 is positioned inside the pouch 18, the tether 22 is grasped by hand or with a laparoscopic grasper and at least a portion of the pouch 18 is pulled into the abdominal wall opening 14. Pulling the tether 22 closes the pouch opening 20. The initial incision can be enlarged to about 15-40 mm, and then the pouch 18 is pulled into the opening 14. If the target tissue 16 is too large to fit through the opening 14, it will be located below the abdominal wall 10 and within the body cavity 12. The remainder of the pouch 18, including the opening 20 of the pouch 18, is pulled into the abdominal wall opening 14 and extends through the opening 14 to the outside of the patient's body and along the upper surface of the abdominal wall 10 as shown in FIG. 1. The pouch 18 can be rolled down and/or pulled taut across the surface of the abdominal wall 10 to maintain its position and allow some tissue retraction at the opening 14.

The guard 28 is inserted through the opening 20 of the pouch 18 and into the pouch 18. The guard 28 has a diameter such that the guard 28 is held in place in the incision/opening 14 when the guard is placed in the opening 14. The guard 28 may also retract tissue at the incision/opening and may therefore be referred to as a retractor. One variation of the guard 28 is shown in FIGS. 2-6 and another variation is shown in FIGS. 7-10. The guard 28 has an inner surface 30 and an outer surface 32 that define side walls interconnected between an apex 34 and a base 36. The inner surface 30 defines a central lumen 38 that extends between the apex 34 and the base 36. The inner surface 30 has a curved funnel-shaped portion located near the apex 34 that may be convex or frusto-conical. The guard 28 has top and bottom circumferential flanges 40, 42 that extend radially outward to provide abutting surfaces against the upper and lower surfaces of the abdominal wall 10, respectively. The top flange 40 may have features such as holes for passing the tether 22 through which the guard 28 is secured to the pouch 18. The guard 28 has an overall length of approximately 2.5 inches (6.35 cm), although guards 28 of various lengths may be used depending on the thickness of the tissue wall 10 to be penetrated. Guards 28 of variable length, such as telescoping or nesting guards 28, are within the scope of the present invention. The inside diameter of the guard 28 at the mid-length is approximately 1.3 inches (3.30 cm), which may be as small as approximately 0.6 inches (1.52 cm). The outer diameter of the guard 28 at the mid-length is about 1.6 inches (4.06 cm), which fits into the incision/opening so that the top circumferential flange 40 is held in place due to the larger overall diameter of the top circumferential flange 40 relative to the diameter of the guard 28 at the mid-length. The wall thickness at the mid-length is about 0.16 inches (4.06 mm), which may be as thick as about 0.3 inches (7.62 mm). The guard 28 is made of any polymer, such as KRATON® or polyethylene, although the guard may be made of any suitable material, including metal. The guard 28 may be flexible to allow the guard 28 to be compressed slightly to facilitate insertion through the opening 14 in the abdominal wall 10. The thickness of the guard 28 and/or the choice of material of construction for the guard 28 are selected so that the guard 28 can withstand cutting and piercing forces from blades, knives, scalpels, morcellators, and the like. The guard 28 acts as a cutting plate or surface against which the target tissue is applied for cutting prior to removal. The target tissue 16 is grasped with a laparoscopic grasper and drawn upward toward the opening 14. At least a portion of the target tissue 16 to be cut is then held in place at the guard 28 location somewhere along the length of the guard 28. A blade, such as a scalpel or morcellator, is then brought into contact with the portion of the target tissue to be cut at the guard 28 location and cuts this portion of the target tissue. The cut portion of the target tissue is drawn through the opening 14 to the exterior surface of the patient, and a new section of the target tissue is brought into position along the guard 28 for cutting and removal. This process is repeated until the entire specimen is removed from the pouch 18, either in whole or in part. The guard 28 serves as a protection for the pouch 18. The physician is free to cut the target tissue at the guard 28 location and against the guard's inner surface 30, thereby reducing the impact of the scalpel or morcellator cutting the pouch 18. Not only does the guard 28 protect the specimen retrieval bag 18 from accidental incision, the guard 28 also protects the surrounding tissue, e.g., the abdominal wall, from accidental incision. The guard 28 preserves the integrity of the bag 18 and effectively maintains a closed incision system. The surgeon can quickly and safely reduce the specimen and remove it from the abdominal cavity.

Once the guard 28 is in place, the surgeon grasps the specimen 16 and pulls it through the incision as far as possible. The surgeon then begins morcellation of the specimen 16 with the scalpel 26, cutting the specimen 16 to reduce its size. Ideally, the surgeon will "hollow" or "skin" the specimen 16 and keep as much of it together as possible. However, more than half of the time, the specimen 16 will break into many small pieces. During morcellation through the incision, the surgeon can maintain a pneumoperitoneum in the abdominal cavity 12 so that the morcellation progress can be viewed laparoscopically through a side port placed in the abdominal cavity 12 at the secondary site. The side port is located external to the pouch 18 and allows the surgeon to see through the transparent pouch or at the pouch itself, ensuring that the pouch maintains its integrity. Once the specimen 16 has been morcellated, crushed, and reduced sufficiently to pass through the incision and withdraw the remaining portions, the guard 28 is removed and the pouch 18 and its contents, including the debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents the remaining debris from remaining within the abdominal cavity 12, maintaining a closed system, whereas in traditional morcellation procedures the surgeon must return to painstakingly search for and collect the scattered debris within the pelvic cavity to prevent it from potentially seeding new tumor sites. The surgeon may choose to do a final view of the patient laparoscopically and then close the wound.

Although abdominal removal and morcellation have been described, the above procedure can also be performed through the vaginal introitus if the cervix has been removed. Following the same process, the pouch 18 is introduced and the specimen 16 is placed laparoscopically into the pouch 18. Instead of pulling the tether 22 through the abdominal wall opening 14, it is pulled through the vagina. In the same manner, the specimen 16 sits at the bottom of the vagina while the pouch 18 advances through the vagina and opens outside the patient's body. The surgeon can roll down or pull the pouch 18 taut to maintain its position and provide some retraction. The surgeon can place a guard 28 through the vagina to protect the integrity of the pouch 18 and maintain a closed system, grasp and remove the specimen 16, and morcellate to reduce the size of the specimen 16. Morcellation of the specimen is performed at and/or against the guard 28, thereby protecting the surrounding tissue and pouch from accidental incision. The surgeon can maintain pneumoperitoneum and monitor the progress of the morcellation laparoscopically. Once the specimen 16 has been morcellated, crushed, and reduced sufficiently to pass through the vagina and withdraw the remaining portions, the guard 28 is removed and the pouch 18 and its contents, including the debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents the remaining debris from being left in the abdominal cavity, thereby preventing harmful materials, such as cancer cells, from seeding the abdominal cavity and maintaining a closed system, whereas in traditional morcellation the surgeon must return to painstakingly search for and collect debris scattered throughout the pelvic cavity and examine the pelvic cavity for debris. The surgeon can choose to do a final laparoscopic view of the patient and close the vaginal cuff and abdominal incision.

In one variation shown in FIG. 11, the guard 28 is configured to be attached to a cap 44, such as a GELSEAL® cap manufactured by Applied Medical Resources Corporation of California. The cap 44 has a rigid ring 46 that is removably connectable to a proximal end of the guard 28. The cap 44 has a lever 48 for locking the cap 44 to the guard 28. The cap 44 has a pierceable portion 50 that can be made of a gel that is configured to seal against instruments inserted therethrough and maintain a pneumoperitoneum in the abdominal cavity. FIGS. 12 and 13 show the cap 44 connected to the guard 28. A recall port 52 can be provided in the cap 44. The cap 44 can be snapped onto the guard 28 and sealingly locked thereto by the lever lock 48 so that a pneumoperitoneum is maintained. FIG. 14 shows the cap 44 with multiple ports 54. Each port 54 is configured to receive a laparoscopic instrument, and each port has one or more internal seals to seal against the instrument when inserted. The multi-port cap 44 advantageously allows for insertion of a grasper, laparoscope, and/or morcellator through a single site.

FIGS. 15-17 show another variation of the guard 28, which has a balloon 56 at the distal end of the guard 28. The balloon 56 is shown in an inflated configuration in FIG. 15. In the inflated configuration, the balloon 56 extends radially outward to form a wide flange for securing to the abdominal wall 10 in the abdominal cavity 12, thereby making it difficult for the guard 28 to be accidentally removed from the opening 14. FIG. 16 shows the balloon in a deflated configuration, which allows the guard 28 to be easily inserted into and removed from the opening 14. The guard 28 of FIGS. 15-17 may also be coupled to the cap 44. The guard 28 may be constructed of any polymeric material, including polycarbonate or similar materials.

The funnel-shaped entry at the proximal end of the guard 28 has been described above. The funnel-shaped entry may be expanded radially outward in another variation to provide a larger surface area against which tissue may be cut. The flared proximal end also helps to hold the pouch in place outside the patient's body and between the guard 28 and the tissue margin 10. In another variation, the guard 28 has a flared distal end that is frusto-conical or curved in shape. The flared distal end may have an expanded radially extending flange that spreads the pouch 18 laterally within the abdominal cavity. The flared distal end helps to keep the pouch in an open position and away from contact with the specimen and away from the distal entry into the guard 28, thereby protecting the pouch 18 from accidental contact with the blade. In the flared distal end variation of the guard 28, the distal diameter of the guard 28 at the distal opening is larger than the diameter of the guard 28 at the mid-length. In a flared proximal end variation of the guard 28, the proximal diameter of the guard at the proximal opening is larger than the diameter of the guard 28 at the mid-length. In yet another variation, the guard 28 has a flared proximal end and a flared distal end that retains the advantages of the variations described above.

Next, a method of tissue removal using the guard 28 with cap 44 will be described. After completing a laparoscopic hysterectomy or any other dissection, the specimen 16 described above is completely dissected from surrounding tissue and awaits removal. The surgeon inserts a specimen bag 18, which may be transparent to the pelvis, and places the specimen 16 in the bag 18. The surgeon then grasps the tether 22 attached to the bag 18 with a laparoscopic grasper and pulls the bag 18 up and into the abdominal wall incision 14 where the trocar is already placed. If necessary, the surgeon expands the incision 15-25 mm before pulling the bag completely through. Since the specimen 16 is too large to pass through the opening 14 while fitting, the specimen 16 is placed inside the pelvic cavity just below the abdominal wall 10, while the remainder of the bag 18 is pulled out of the incision and opened outside the patient's body as shown in FIG. 1. The surgeon can roll down the pouch or pull it taut to maintain its position and provide some retraction. The surgeon then inserts the guard 28 into the incision to protect the pouch 18 and abdominal wall 10 during morcellation and to retract the incision. The pouch integrity is maintained and a closed system is maintained.

The guard 28 is placed in the opening 28 of the pouch 18 and positioned in the incision so that the guard 28 extends across the tissue margin 10. The cap 44 is coupled to the guard 28. The cap 44 snaps onto the proximal apex flange 40 and the lever 48 of the cap 44 is moved to the locked position to seal the cap 44 to the guard 28. The guard 28 may have a stiffening wire 58 to maintain the shape and rigidity of the apex flange 40. The wire 58 is visible in FIGS. 1, 5, 6, 10 and 12. With the cap 44 in place, the pouch 18 may be insufflated. In one variation, only the pouch 18 is insufflated to inflate it against the abdominal cavity 12. In another variation, both the pouch 18 and the abdominal cavity 12 are insufflated. In another variation, both the pouch 18 and the abdominal cavity 12 are insufflated so that the pressure in the pouch 18 is greater than the insufflation pressure in the abdominal cavity 12. Insufflation may be provided via a trocar inserted through the cap 44 or via an insufflation port 52 in the cap 44. With the cap 44 in place, the powered morcellator 24 is inserted through the penetrable portion 50 of the cap 44 and into the interior of the pouch 18. Alternatively, if a multi-ported cap 44 is used, the morcellator 24 may be inserted through one of the ports 54. A surgical grasper is also inserted into the cap 44, either through the penetrable portion 50 or one of the ports 54, and the target tissue is grasped and pulled proximally towards the opening and into the central lumen 38 of the guard 28, where it is morcellated within the protective zone provided by the guard 28. As discussed above, the guard 28 protects the pouch 18 from puncture, thereby helping to maintain a closed morcellation system. The powered morcellator 24 is placed through the gel cap 44 to a depth that maintains the bladed distal end 60 of the powered morcellator 24 within the central lumen 38 and the protective area or length of the guard 28. The grasper draws the target tissue toward the blade 60 for morcellation and removal. The removed tissue will travel through the central lumen of the powered morcellator 24.

Rather than placing the morcellator 24 through the pierceable portion 50 of the cap 44, a stabilizer is provided that cooperates with the bag 18 or guard 28 to help hold the morcellator 24 in place at a depth within a protective zone in the central lumen 38 of the guard 28. By maintaining the morcellator within the lumen 38 of the guard 28, the morcellator 24 is prevented from contacting the walls of the bag 18 during the procedure, thereby protecting the bag from accidental tearing. Variations in the stabilizer are further described below.

After positioning the morcellator 24 and cap 44, the surgeon may choose to insufflate the pouch 18 and abdominal cavity 12. The surgeon may view the position of the morcellator 24 and target tissue 16 as well as the integrity of the pouch 18 to ensure that the pouch is not twisted or too close to the distal end 60 of the morcellator 24. Viewing is accomplished with a laparoscope placed through a port 54 at the same incision site or through a secondary incision site that serves as a lateral port. The specimen 16 is grasped by the tenaculum and pulled into the powered morcellator 24 to reduce its size. Ideally, the surgeon will "hollow out" or "strip" the target tissue to keep it as whole as possible. However, more than half of the time, the target tissue breaks into many small pieces. Once the specimen 16 has been morcellated sufficiently to pull the remaining tissue through the incision, the morcellator 24, gel cap 44 or stabilizer, and guard 28 retractor are removed and the pouch 18 and its contents, including debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents remaining debris from being left behind in the abdominal cavity 12, maintaining a closed system, whereas in traditional morcellation procedures the surgeon must return to painstakingly search for and collect scattered debris in the pelvic cavity to prevent potentially seeding new tumor sites. The surgeon chooses to perform a final view of the patient laparoscopically and then close the wound.

Although abdominal removal and morcellation have been described, the powered morcellation technique described above can also be performed through a body orifice, such as the vagina. Following the same process, the pouch 18 is introduced and the specimen 16 is placed into the pouch 18 laparoscopically. Instead of pulling the tether 22 through the abdominal wall opening 14, the tether 22 is pulled through the vagina. In the same manner, the specimen 16 is positioned at the bottom of the vagina while the pouch 18 is advanced through the vagina and opens outside the patient's body. The surgeon may roll down or pull the pouch 18 taut to maintain its position and provide some retraction. The surgeon places the guard 28 through the pouch 18 via the vagina to protect the integrity of the pouch and maintain a closed system, places the cap 44 over the guard 28, and places the powered morcellator 24 through the gel cap 44 or stabilizing cap. The surgeon then grasps the specimen 16 with the tenaculum and passes it through the powered morcellator 24 and out via the vagina, thereby reducing the size of the specimen 16. The surgeon maintains pneumoperitoneum and monitors the progress of the morcellation laparoscopically. Once the specimen 16 has been morcellated sufficiently to retract the remaining portion through the vagina, the morcellator 24, gel cap 44 or stabilizing cap, guard 28 and/or retractor are removed, and the pouch 18 and its contents, including the debris generated during morcellation, are withdrawn from the patient. The pouch 18 prevents the remaining debris from being left in the abdominal cavity 12 and maintains a closed morcellation system, whereas in traditional morcellation techniques the surgeon must return to painstakingly search for and collect debris scattered throughout the pelvic cavity and examine the cavity for debris. The surgeon may choose to perform a final laparoscopic view of the patient, and close the vaginal cuff and abdominal incision.

18 and 19, there is shown a retractor 62 having a first ring 64 and a second ring 66 connected to each other by a flexible side wall 68. The retractor 62 is described in detail in one or more of the patent documents incorporated by reference in this application. The second ring 66 may be compressed and inserted through a small incision where it expands to form an attachment means to the abdominal wall 10 in the abdominal cavity 12. The first ring 64 is positioned outside the patient's body above the abdominal cavity 10 where it can be lowered by rotating or inverting itself to retract and widen the abdominal wall opening 14. The retractor 62 may be employed in any of the variations described above. In use, the retractor 62 is inserted prior to the insertion of the bag 18 into the body cavity or opening. In one variation, the first ring 64 has a larger diameter than the second ring 66 as shown in FIG. 19. The larger diameter of the first ring 64 relative to the second ring 66 allows for a larger space to work and cut tissue. The sidewall 68 is made of a polyurethane laminate or similar material, including a nonwoven fabric that resists cutting into the sidewall 68.

20A and 20B show a modified retractor 62 configured in a bag 70. The bag 70 has a first ring 64 and a second ring 66 connected to each other by a flexible, substantially cylindrical side wall 68. The opening at the second ring 66 is closed by a depending bag portion forming the base 72 of the bag 70. The bag 70 is inserted and used in the same manner as described above for the bag 18. The second ring 66 is compressed and fed through a small incision into the abdominal cavity 12. The side wall 68 is wrapped around the top ring 64 to retract and open the opening 14, with or without the use of a guard 24 at the opening in the bag 70 that is connectable to the first ring 64. The specimen 16 is removed by manual or powered morcellation in the same manner as described above. The first ring 64 is also connectable to a gel cap 44.

21-24, the pouch 70 is shown with only the first ring 64 forming the opening, the flexible cylindrical side wall 68 and the base 72. The first ring 64 is elastic and compressible into a collapsed elongated configuration suitable for advancing through a small incision or through the lumen of a trocar. The arrows shown in FIG. 22 indicate the vertical collapse direction of the pouch 70. The collapsed pouch 70 is then easily compressed laterally and deployed in the abdominal cavity. The first ring 64 is compressed to give it an elongated shape. The compressed pouch will form its original shape with the first ring 64 in an expanded state. In the expanded configuration, the pouch 70 is easily oriented in the abdominal cavity 12. The collapsed pouch 70 is conveniently flattened in the abdominal cavity, and the pouch has two sides. In the collapsed configuration, the pouch 70 is not right-side up. 23 and 24, the bag 70 may be twisted to form a spiral configuration to collapse or shorten the length of the bag. This feature is advantageous not only for insertion of the bag through a small incision, but also for lifting the sample closer to the opening of the bag as the sample is being morcellated. The first ring 64 acts as a circumferential guide for sample placement and may be brightly colored to facilitate laparoscopic viewing. After the sample is placed within the perimeter of the first ring 64, the first ring 64 is grasped and lifted to place the sample into the bag 70. The same is true for the two-ring bag 70 described above. As shown in Figs. 23 and 24, the bag 70 may be twisted to form a spiral configuration to collapse or shorten the length of the bag. This feature is advantageous for insertion of the bag through a small incision, as well as for lifting the sample closer to the opening of the bag as the sample is being morcellated.

25, there is shown a guard 74 configured for use with the retractor 62 shown in FIGS. 18 and 19 or the pouch 70 of FIGS. 20-24. The guard 74 has a rigid ring 76 with a plurality of inwardly extending flaps 78 that meet at a center or form a central opening 80 as shown in FIG. 25. The flaps 78 are attached to the ring 76 such that they flex relative to the ring 76, thereby allowing the target tissue 16 to be removed past the flaps 78. The flaps 78 also flex distally to allow the insertion of instruments past the guard. The flaps 78 are made of the same material as the guard 28, e.g., polycarbonate, LDPE, HDPE, or similar material, so that the flaps 78 are sufficiently resilient and cut-resistant to resist penetration by a blade, thereby protecting the retractor 62 or pouch 70. The guard 74 may consist of a single ring 76 with a flap 78 or may consist of two similar rings 76a, 76b with flaps 78a, 78b, respectively. The two rings 76a, 76b are connected together such that the flap 78a is offset from the flap 78b to form a layered flap arrangement that allows protection between the flaps 78a, 78b. The target tissue 16 is raised through the openings 80a, 80b, and when it is in the vicinity of the guard 76, the target tissue 16 is severed. The target tissue 16 can also be severed when positioned against the flaps 78a, 78b.

26, the guard 74 has an upstanding flat perimeter wall 82 configured to snap under the first ring 64 or bladder 70 of the retractor 62 as shown in FIG. 29. The guard 74 may further include a flange 84 configured to snap into the first ring 64 or bladder 70 of the retractor 62 as shown in FIG. 28. FIG. 27 shows a rigid guard 74 without flaps. The rigid guard 74 of FIG. 27 provides a wide cutting surface against which the target tissue can be cut without flexing as much as a guard 74 with flexible flaps 78. The guard 74 may further include a funnel-shaped depending portion 86 that provides increased vertical protection for the bladder 70/retractor 62 and/or wound. The guard 74 is positioned on top of the retractor 62 or bladder 70 and within the perimeter of the first ring 64. The guard 74 is then snapped under the first ring 64 to join the guard 74 to the first ring 64. The guard 74 is also made of a material that resists penetration when being morcellated, helping to keep the bag 70 or retractor 62 in place. In other variations, the guard is configured to snap onto the ring.

30, a trocar 88 is shown having a first balloon 90 and a second balloon 92. The trocar 88 has a removable seal housing 94 with one or more seals that seal against the inserted instrument. The trocar 88 has a central lumen 96 extending through the seal housing 94 and the trocar 88. The lumen 96 is sized and shaped to receive the powered morcellator 24. The trocar 88 may further include an obturator (not shown) configured to penetrate the abdominal wall. The trocar 88 may be inserted through the gel cap 44 described above or directly through an incision made in the abdomen. The bag 18, 70 may be deployed through the lumen 86, and the specimen 16 may be inserted into the bag 18, 70. The tether 22 of the bag 18 or the first ring of the bag 70 is pulled through the incision and the trocar 88 is reinserted. The second balloon 92 is inflated. In the inflated configuration, the second balloon 92 extends laterally to push the pouch 18, 70 laterally and away from the distal end of the trocar 88 and away from the bladed distal end of the morcellator. The powered morcellator 24 is inserted into the lumen 96 of the trocar 88. The morcellator 24 may be prevented from extending beyond the distal end of the trocar 88 by a stop formed on the trocar 88 against the morcellator 24. A tenaculum is inserted into the lumen of the morcellator 24 to grasp and draw the tissue toward the morcellator. The tissue is cut and removed from the specimen bag. The first balloon 90 is inflated so that it is positioned above the abdominal wall. Both the first balloon 90 and the second balloon 92 help hold the trocar 88 in place against the abdominal wall 10. FIG. 31 shows another trocar 88 with a seal housing 94 and an air insufflation port 98 for inflating at least one balloon 92.

32-39, the stabilizer 100 will now be described. The stabilizer 100 has a flange 102 configured to couple to the bag 18, 70 or guard 28. The stabilizer 100 has a central portion 104 defining a lumen 106 and housing a lock 108. The lumen 106 is sized and configured to receive the powered morcellator 24. Once inserted into the lumen 106, the height of the morcellator 24 relative to the abdominal wall can be adjusted and then the morcellator can be locked in place by the lock 108. The lock 108 has an unlocking configuration in which a lever 110 is released to allow the morcellator 24 to translate vertically within the lumen 106. The lock 108 also has a locking configuration that pushes the lever 110 to lock the morcellator 24 against translation. The lock 108 acts to increase the frictional force against the shaft of the morcellator 24 that holds the lock in place.

40 and 41, the stabilizer 100 is shown coupled to the motorized morcellator 24. The system of FIG. 40 and 41 includes a ratchet drive mechanism including a toothed bar on the morcellator 24 and configured to engage a pawl (not shown) in the central portion 104 of the stabilizer 100. A button 114 is provided on the stabilizer 100 to disengage and engage the pawl to unlock and lock the stabilizer 100 from the morcellator 24 to free or prevent their relative vertical translation. The morcellator 24 includes an integral scope and illuminator 116, an air insufflation port 118, and a mechanical drive connection 120 that rotates the morcellator blade 122. The stabilizer 100 includes a lower flange 102 that extends outwardly to engage a bag, retractor, or guard, as described above. In one variation, the stabilizer 100 is configured to prevent actuation of the morsel 24 when the stabilizer pawl is located within a certain range of the toothed bar 112, thereby providing a safety shutoff mechanism so that the morsel 24 cannot be actuated when it is too far or beyond the range of the guard and therefore in a position that may cause accidental contact with the bag. Another variation of the stabilizer 100 is shown in Figures 42 and 43, where like numerals are used to indicate like parts. The stabilizer 100 has a different shape and the pawl element 122 is visible in Figure 43.

Figures 44 and 45 show a bag 18 with a tether 22 and a flexible ring 64 located at the opening 20. The bag material may be clear or opaque, and the ring 64 is compressible for insertion through a small incision. Wrapping a side wall 68 around the first ring 64 reduces the height of the bag, thus elevating the specimen closer to the opening, thereby making the specimen accessible for morcellation.

FIGS. 46 and 47 show a pouch deployment or deployment instrument 124 for the pouch 18 of FIG. 47. The instrument 124 is insertable through a trocar. The pouch 18 has an opening 20, a tether 22, and a deployment cap 21.

48 and 49 show another bag variation having a first ring 64, a second ring 66, a sidewall 68 between the first and second rings, and a base 72. The resilient second ring 66 located at the bottom of the bag 18 allows the bag to flare open when placed in the body cavity 12 and also helps prevent objects from sticking to the specimen 16. After the specimen is placed in the bag 18, the first ring 64 is pulled to the surface of the abdominal wall 10 as shown in FIG. 49.

Figure 50 shows the pouch 18 having a first ring 64 made of Nitinol that provides support to hold the pouch 18 open within the abdominal cavity 12 while allowing easy insertion through a small incision.

50A-50D show the bag 18 according to various embodiments in an uncollapsed state or an expanded or partially expanded state. As shown, the bag 18 has a closed end 126 and at least one open end 128. The open end 128, according to various embodiments, has a tether or drawstring 130 that encircles the open end 128 of the bag 18. Manipulation of the tether 130 closes the open end 128 of the bag 18. The illustrated bag 18 has a plurality of preformed folds 132 or predefined deformation patterns in a wall 134 of the bag 18 between the closed end 126 and the open end 128 of the bag 18. According to various embodiments, the bag 18 is formed to provide a tendency for the bag 18 to collapse and flatten, and in such collapsed and flattened state, a minimum height is provided with the open end 128 facing upward or toward the opening of the body cavity and having a maximum width, diameter or opening dimension, and the closed end 126 facing away from the opening of the body cavity and configured to lie flat and stable along the body cavity. According to various embodiments, when a force is applied in one direction, the height of the wall 134 of the bag 18 increases to capture or surround the specimen within the bag 18. The folds 132 or deformation pattern ensure that such increase in height of the bag 18 occurs in proportion to the direction of the force being applied. According to various embodiments, a weight, specimen or a counter force is applied to the bag 18 to further aid in the increase in height of the bag 18, or in particular, the proportional increase in height of the bag 18.

In one embodiment, the bag 18 is folded flat or accordioned prior to deployment within the patient's body. Upon deployment, the bag 18 is flat with the open end 128 of the bag 18 on the top and the closed end 126 on the bottom. The closed end 126 is on the bottom, for example, within the patient's body cavity. Thus, the open end 128 of the bag 18 remains open and thus does not need to be held open due to the pattern formed on the wall 134 of the bag 18. Additionally, due to the pattern, the open end 128 is biased open and resists closing. The difficulty and time of placing a specimen on and/or within the bag is thereby reduced.

The surgeon places the specimen on top of the bag 18 on or over the open end 128 of the bag 18. By pulling on the tether 130, the walls 134 of the bag 18 are pulled up and around the specimen, thereby containing the specimen. The opposing pulling forces on the tether 130 and the weight of the specimen on the bag 18 cause the deformation pattern along the walls 134 of the bag 18 to unfold or straighten. In one embodiment, the bottom or closed end 126 of the bag 18 has a weight or an attachable weight to provide sufficient opposing force to straighten the walls 134 of the bag 18 when the tether 130 is pulled. In one embodiment, one or more tabs 136 or portions of the bag 18 around the open end 128 of the bag 18 are provided to allow the walls 134 of the bag 18 or one or more folds 132 of the walls 134 to unfold even with the force of pulling the bag 18 toward an opening in the body cavity or pulling the bag 18 toward the opening in the body cavity.

In one embodiment, when the weight of the specimen pulls down on the bag 18, this pulls the shorter sides of the bag 18 downward, reducing the overall packing size. According to various embodiments, to compensate for or reduce the reduction in overall packing size, one or more tabs 136 are provided at the open end 128 of the bag 18 that are located on the flattened sides of the bag 18 and prevent the bag 18 from reducing its overall packing size. Thus, in one embodiment, when the bag 18 is flattened, the distance along the edge of the bag 18 is greater than the distance along the cross-section of the bag 18. The tether 130 is threaded through the tabs 136 in one embodiment.

For a particular desired height and/or width of the bag 18, the patterns shown in Figures 50E and 50F are used to optimally form a wall pattern that ensures proper deployment and manipulation (e.g., straightening and containment). In one embodiment, the bag 18 is preformed with the pattern shown, and the bag 18 is then heated to maintain the flat and patterned state. A tether 130 is attached or threaded through tab 136 at the open end 128 of the bag 18. Thus, the heat, pressure or preforming conditions that place the bag 18 in its initial flat, stabilized and patterned state help to maintain the deformed pattern, thereby allowing the bag 18 to collapse and deform or be biased when placed in the body cavity. A downward force applied to the center of the bag 18 helps the folds 132 to straighten or unfold, thereby expanding or lengthening the bag 18 and increasing its height to encase the specimen. As shown, the valleys and/or peaks of the pattern may have the same height and/or width to further ensure a linear and constant or measured increase in size. In various embodiments, the valleys or peaks of the pattern may have different dimensions from one another and apply equal forces to the inner wall of the cylindrical deployment tool, thereby reducing the force required to deploy the bag 18.

According to various embodiments, the top or open end and bottom or closed end of the bag are twisted in alternating directions, thereby forming a spiral pattern on the walls of the bag. The bag and/or the spiral is heated or compressed to retain these shapes. The spiral folds help keep the bag flat after insertion into the body. After the specimen is placed on the open end of the bag, pulling on the tether encircling the open end of the bag causes the walls of the bag to unfold or untwist. Thus, due to opposing pulling forces on the tether or open end of the bag and the weight of the specimen and/or attached or added weight at the closed end or bottom of the bag, the bag untwists and encases the specimen as it is pulled towards the opening of the body cavity. According to various embodiments, the open end has a first ring and/or the closed end has a second ring. The first and/or second rings may be reinforced or have wires or rods to bias the open ends into an open or expanded state to receive the specimen, increase the tendency of the bag to remain flat or unexpanded, or provide weight to aid in the expansion of the bag, or provide stability in the placement of the bag or in receiving and capturing the specimen.

According to various embodiments, the top or open end and the bottom or closed end of the bag are crushed directly towards each other. Wrinkles or creases in the walls of the bag between the open and closed ends of the bag help to keep the bag flat after being heated or compressed to retain these patterns/shapes and to keep the bag flat after being inserted into the body. After the specimen is placed on the open end of the bag, pulling on the tether surrounding the open end of the bag causes the wrinkles in the walls of the bag to unfold or straighten the walls of the bag. Thus, due to the opposing pulling forces on the tether or open end of the bag and the weight of the specimen and/or the attached or added weight at the closed end or bottom of the bag, the bag straightens out to encase the specimen as it is being pulled towards the opening of the body cavity. According to various embodiments, the open end has a first ring and/or the closed end has a second ring. The first and/or second rings may be reinforced with or have wires or rods to bias the open ends into an open or expanded state to receive the specimen, increase the tendency of the bag to remain flat or unexpanded, or provide weight to aid in the expansion of the bag, or provide stability in the placement of the bag or in receiving and capturing the specimen.

As shown in Figures 50G and 50H, the bag 18 may have a variety of upper, base and overall shapes, including but not limited to, cubes, prisms, cylinders, spheres, dodecahedrons, hemispheres, cones, rectangular prisms, polyhedrons, etc., with one or more openings and with a variety of modified wall patterns such that the bag tends to remain in a collapsed or substantially flat shape and expands in a linear or controlled manner when manipulated to receive and encase a specimen.

Various examples of access systems to be included or integrated into a morcellation system, where the entire access system, portions of the access system, or a combination of the access system and/or components thereof are arranged to provide channels and/or approximate areas in accordance with various embodiments of the present invention, are shown in U.S. patent application Ser. Nos. 13/865,854, filed April 18, 2013; 61/880,641, filed September 20, 2013; 12/578,422, filed October 13, 2009; 61/104,963, filed October 13, 2008; 12/358,080, filed January 22, 2009; and 11/374,188, filed March 13, 2006. No. 11/683,821 filed March 8, 2007, No. 12/396,624 filed March 3, 2009, No. 14/209,161 filed March 13, 2014, No. 12/873,115 filed August 31, 2010, No. 12/840,989 filed July 21, 2010, No. 10/2006, ...2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. 12/2006, No. No. 11/548,758, filed on May 12, 2003, No. 10/516,198, filed on November 30, 2004, and No. 10/666,579, filed on September 17, 2003, which are incorporated by reference herein and the disclosures of which are incorporated by reference as if set forth herein.

51-53, another variation of the guard or shield 200 of the present invention is shown. The guard 200 is generally in the shape of a spiral. The guard 200 has a first inner end 202 and a second outer end 204. The first end 202 and the second end 204 are connected to one another by a central portion 206, also referred to as a leaf or band. The guard 200 has an apex end 212, also referred to as a trailing or proximal end, a bottom end 214, also referred to as a leading or distal end, and inner and outer surfaces 208 and 210 connected to one another by the first inner and second outer ends 202 and 204. The central portion 206 or band has a concave outer surface 210, and the inner surface 208 forms a conformal surface that is convex when viewed from the interior of the spiral. The band recess is parabolic in one variation, with an inflection point located halfway between the apex end 212 and the bottom end 214, although the invention is not so limited, and the inflection point may be located anywhere between the apex end 212 and the bottom end 214, or even coincident or nearly coincident with the apex end 212 or the bottom end 214. The band 206 may not include a recess, and the band 206 may simply be curved or straight along at least a portion of the guard 200 between the apex end 212 and the bottom end 214. The guard 200 is shown as symmetrical, with the apex end having the same outer diameter as the bottom end. In another variation, the guard 200 is asymmetrical in shape, and the guard may have an apex end that is larger or smaller in diameter than the bottom end. The guard 200 is also vertically symmetrical, although the invention is not so limited, and the guard 200 may have a central axis that is angled with respect to a reference horizontal plane. The guard 200 has a spiral shape such that a portion of the band is curved and overlaps another portion of the band in a circular or elliptical manner. Specifically, at least a portion of the outer surface 210 of the band 200 overlaps and faces at least a portion of the inner surface of the band 200 such that a recess in one portion of the band 200 is adjacent or juxtaposed to a recess in another portion of the band, telescoping and nesting one portion of the band within the other portion of the band. The spiral is shown as having a resting and mechanically unstressed configuration with one and a half turns having a circumferential length of approximately 3πR, where R is a radius taken perpendicular to the longitudinal axis of the guard 200. The present invention is not limited to guards having exactly 1.5 turns, but may have more or less turns as desired according to the size, shape and desired force distribution and function, e.g., retractor and/or retention, for a particular incision size. A particular advantage of the spiral guard 200 is that its shape and size can be changed, expanded or contracted. In essence, the band can slide on itself to form a larger diameter spiral configuration or a smaller diameter spiral configuration. The spiral guard 200 has a central lumen 216 formed by the spiral, which can also be expanded by expanding or opening it. The size of the central lumen 216 can also be reduced by closing the spiral or reducing the size of the helix by sliding the band into a tight curl that creates a large number of turns on itself, or into a larger curl that creates a large diameter with fewer turns. The central lumen 216 is substantially circular in shape, although the invention is not so limited and the central lumen 216 can be elliptical or variable in shape. Thus, the spiral guard 200 can be adjusted when inserted into a wound or incision of a patient or into a pouch placed inside the patient's body as described above, along with other guards. Depending on the size of the incision, the spiral shield 200 can be adjusted larger or smaller by opening or closing the spiral shape, and the guard can curl on itself to form more turns, thereby fitting the wound opening or pouch accordingly. Furthermore, the spiral shield 200 can be molded with a predetermined bias for a particular rest or normal diametric position, shape and size. For example, if an incision of about 1 inch (2.54 cm) is to be made in a patient, the size of the spiral shield 200 having a rest diameter of about 2 inches (5.08 cm) can be reduced by twisting the spiral shield 200 on itself to increase its number of turns, thereby reducing its diameter. While in the reduced configuration, the spiral shield 200 is inserted into the 1 inch (2.54 cm) incision and then released. In contrast, because a bias is molded into the spiral shield 200, the spiral shield 200 will tend toward its normal configuration and thus expand from its contracted configuration, advantageously retracting the incision while simultaneously sealing or pressing against the incision holding the spiral shield 200 and anything between the shield 200 and the incision, such as a pouch in place relative to the patient. Alternatively, the shield 200 is advantageously collapsible under tissue forces when inserted into the incision. The tissue forces against the shield can reduce the diametrical dimensions of the shield. Because the shield is adjustable, the size of the central opening or lumen 216 can be increased by opening the spiral for removal of large specimens. This adjustability advantageously reduces strain on the surrounding tissue, keeps the incision site as small as possible, reducing the risk of infection, while at the same time allowing the incision size to be made smaller or larger by opening the spiral as needed to withdraw specimens from the body. In some cases, the dimensions of the tissue to be removed are unpredictable, and this adjustability can advantageously facilitate removal of an extensive tissue sample without creating difficulties for the physician.

The position of the spiral shield 200 is further advantageously held against the incision site or natural body orifice, e.g., the vagina, with the aid of a curvature or recess in the band. Specifically, the apex end 212 forms a top lip, also called a top flange, which extends circumferentially at least in part over the top surface of the tissue. The bottom end 214 forms a bottom lip or flange which extends circumferentially at least in part over the top surface of the tissue, abdominal wall or surgical workspace within the patient's body cavity, advantageously retracting the tissue away from the cut surface of the shield 200, which is typically the inner surface 208 of the band. The tissue is received against the outer surface 210 of the band, which fits within the recess or curved shape of the outer surface 210, thereby holding the shield and containment bag in place, and the flange prevents the shield from sliding down into or up into the patient's body. Of course, the shield 200 is placed directly into the surgical incision/body opening or into any one or more of the containment pouches and wound retractors described above. Morcellation can proceed by any technique or manner chosen by the surgeon, including using the inner surface 208 of the shield 200 as a cutting plate, with a blade being used to cut tissue against the cutting plate that has been retracted by a grasper through or into the central lumen 216. Once the tissue to be morcellated is drawn up through the central lumen 216, it can be positioned against the inner surface 208 of the guard 200, and a blade or scalpel can be used to cut the tissue against the shield 200. The shield 200 is made of any suitable material, such as any polymer or metal. One suitable material is ultra-high molecular weight polyethylene plastic. Another suitable material is linear low density polyethylene. The shielding material has an optimized thickness to protect the tissue without easily puncturing or cutting when the tissue is cut against the shielding material. Once morcellation is complete, the diameter of the spiral shield 200 can be reduced by rolling the shield on itself into a reduced configuration that allows for easy removal from the surgical site. Alternatively, the shield 200 can be removed by pulling the shield 200 vertically or along the longitudinal axis of the shield.

52 and 53 show the core pin-shaped spiral shield 200 in a forming mold 220 in the shape of a spiral. To manufacture the spiral shield 200 by injection molding, the shield 200 is molded onto the spiral mold 220. Once the core pin of the mold 220 is unwound, the shield 200 can be brought into its functional spiral form by pushing one end in front of or behind the adjacent winding. Because the shield 200 is initially formed in a spiral and then spiralized, the shield 200 has some springback tension memory effect therein, whereby the shield 200 tries to assume a spiral shape without remaining fully spiraled. If the shield 200 has an undesirable and excessive amount of spring bias tension, an annealing process can be performed by placing the shield 200 in an oven at an appropriate temperature for an allotted time, and then removing it, thereby reducing or eliminating the residual tension in the shield 200. However, in one version of the shield 200, some residual tension is advantageously desired because the tendency of the shield 200 to expand along its longitudinal axis facilitates removal of the instrument from the incision site. A tab (not shown) can be formed on one end of the shield 200, e.g., the proximal, inner or outer end, and/or a hole can be formed near one end of the shield, through which a drawstring can be attached so that the surgeon can pull the string or tab to easily remove the shield 200 from the incision site. The tab or hole can indicate a directional preference for inserting the shield, so that helical tension can be utilized for instrument removal with the tab/hole located outside the patient and near the surgeon. In one version, the first inner end 202, which is conformed to the inside of the winding, is provided with a tab or hole for this removal feature. During removal, as the inner end 202 is pulled vertically, the band of the shield gradually stretches out of the incision site.

As an alternative to injection molding, the spiral shield 200 may be manufactured from plastic sheet material and may be die cut or thermoformed into the desired shape. Also, rather than injection molding the shield 200 into a spiral shape, the spiral shield 200 may be injection molded directly into the shape of a spiral.

71A and 71B, the shield 200 is shown in an expanded elongated configuration and a compressed or unexpanded configuration, respectively. The expanded configuration of the shield 200 is also shown in detail in FIGS. 72-74. In the expanded configuration, the shield 200 is convertible to a compressed configuration by overlapping the inner surface 208 over the outer surface 210. The compressed configuration of the shield 200 is also shown in FIGS. 76-79. At least a portion of the shield 200 overlaps itself in the unexpanded configuration as clearly shown in FIGS. 78A-78C. In FIG. 78C, a portion of the shield 200 is shown fitting into a recess in the outer surface 210 of an adjacent overlapping portion of the shield 200. The shield 200 is adapted to be at least partially wrapped or curled about the longitudinal axis 218. The shield 200 is adapted to be at least partially rolled or curled on itself about the longitudinal axis 218 such that one portion of the shield 200 overlaps or is positioned in juxtaposition or contact with another portion of the shield 200. When in the unexpanded configuration of FIG. 71B, the shield 200 has a relaxed or normal lateral configuration in addition to a compact configuration in which the unexpanded configuration is wound into a tight roll having a reduced diameter or lateral dimension suitable for insertion into a wound or body opening. The shield 200 has a bias toward the relaxed or normal lateral configuration which the shield will tend to move toward after insertion into a wound or body opening, thereby exerting some retraction force on tissue as the shield 200 expands from the compact configuration to the larger configuration, depending on the material used for the shield 200 and the forces exerted by the surrounding tissue in response to the shield 200 in the inserted state. If the wound or body opening is tight, the shield 200 may not expand from its reduced lateral insertion configuration, or may expand slightly only in the lateral dimension as the shield tends toward its normal relaxed configuration, thereby unrolling slightly, or the shield 200 may fully expand to its normal relaxed configuration.

71A is a result of the shield 200 being molded onto a helical mold 220. The shield 200 defines a longitudinal axis 218 along which a center of the shield 200 is located. The shield 200 is made at least in part of a material that is biased toward a vertically extended position. The shield 200 may be made of a shape memory material or may have a portion made of a shape memory material. When in the vertically compressed configuration, the bias towards the vertically expanded configuration does not result in the shield 200 springing into the vertically expanded configuration because the recesses in the outer surface form a top lip, also referred to as top flange 222, and a bottom lip, also referred to as bottom flange 224, such that at least a portion of the top flange 222 abuts the adjacent overlapping top flange 222 while in the compressed configuration, and at least a portion of the bottom flange 224 abuts the adjacent overlapping bottom flange 224 while in the compressed configuration, thereby preventing the vertically compressed configuration from easily flipping into the vertically expanded configuration. At least one of the top flange 222 and bottom flange 224 serves as a stop that prevents the shield 200 from expanding from the compressed configuration into the expanded configuration. The bias towards the expanded configuration exerts some frictional force on the device itself, which helps to regulate the lateral or diametric expansion of the shield 200. When in the compressed configuration, the shield 200 may be rolled/curled about the longitudinal axis, thereby reducing the diametric or lateral dimensions, thereby reducing the dimensions of the shield 200 and reducing the diameter of the central lumen 216, thereby facilitating insertion through a small, minimally invasive incision or body orifice.

80 shows the shield 200 in a relaxed or normal lateral configuration having about 1.25 times the circumference of the peripheral windings, and shows the central lumen 216 with the shield inner or lumen inner diameter 226 and the shield diameter 228 or outer diameter, either of which serves as the lateral or diametric dimension for the shield 200. FIG. 81 is a plan view of the shield 200. In FIG. 81, the shield 200 is in a compact configuration suitable for insertion into an incision/body opening through which the shield 200 is wound on itself in a tight roll. The shield 200 of FIG. 81 has a reduced lumen diameter 226 and shield diameter 228 relative to the relaxed normal configuration of FIG. 80, having about 2.25 times or more the circumference of the peripheral windings. The overlapping portions of the shield 200 are in contact with each other and act to slightly frictionally hold the reduced lateral diameter position, but the shield 200 tends to assume its normal configuration as the lateral dimension bias is toward its unstressed or relaxed radially normal configuration. The compact configuration with reduced lateral dimension is adapted for proper insertion into a wound or body opening. From the compact configuration, the shield 200 expands from the reduced lateral dimension position to its normal unstressed lateral dimension configuration upon release when positioned outside the wound or body opening. This expansion in situ may be limited by forces exerted by tissue in response to forces exerted by the shield 200 in the inserted state. Although the shield 200 has a central lumen 216 that is circular in shape and has a diameter, the invention is not so limited, and variations include shields 200 having elongated lumens 216 with a length greater than their width, e.g., oval or elliptical lumens. Thus, the outer periphery of the shield 200 may or may not have a corresponding shape. In variations in which the outer periphery of the shield 200 has a shape that matches the shape of the central lumen 216, if the lumen 216 is circular, the outer periphery of the shield 200 is also circular, or if the central lumen 216 has an oval or elliptical shape, the outer periphery of the shield is also oval or elliptical.

As mentioned above, the shield 200 has a top flange 222 and a bottom flange 224 as part of the concave outer surface 210 of the shield 200. While in the vertically unexpanded configuration, the shield 200 is generally symmetrical about a plane perpendicular to the longitudinal axis 218, where the top flange 222 and the bottom flange 224 extend radially outwardly from the longitudinal axis 218 over a suitably equal distance, as shown in FIG. 77. Referring to FIG. 79, a variation of the shield 200 is shown in which the shield 200 is not symmetrical about a plane perpendicular to the longitudinal axis 218. In FIG. 79, the top flange 222 extends radially outwardly from the longitudinal axis 218 over a greater distance than the bottom flange 224, which extends radially outwardly from the longitudinal axis 218. The shield 200 thereby forms an enlarged top flange 222 relative to the bottom flange 224. The enlarged top flange 222 advantageously provides a large surface area for protection of the surrounding tissue and/or containment pouch as well as providing a large cutting board surface for use by the surgeon when morcellating/reducing tissue.

82, a variation of the shield 200 is shown with a finger pull or tab 230. The tab 230 is shown integrally molded at or near the first inner end 202 of the shield 200. The tab 230 extends from the first inner end 202 and the apical end 212 of the shield 200, forming an extension adapted to be easily grasped by a user, either by the user's finger or by an instrument, such as a grasper. In one variation, the tab 230 has a hole 232 configured to provide a location for insertion of an instrument or finger. In another variation, the hole 232 is not provided. The tab 230 is configured such that pulling the tab generally upward or in a proximal direction changes the shield 200 from the unexpanded configuration to the expanded configuration. As a result of the upward force applied at the first end 202 via the tab 230, the bottom flange 224 of the first end 202 disengages or breaks away from the adjacent lower flange 224 of the shield 200, thereby moving the first end 202 away from the mating position with the overlapping curvature of the adjacent shield 200 portions. When the proximal end of the tab 230 is pulled upward, this causes a vertical expansion of the shield 200, first resulting in the first inner end 202 breaking away from the unexpanded configuration and the remainder of the shield 200 gradually moving out of the mating apposition of the unexpanded configuration into the spiral shape of the shield 200 in the expanded configuration. FIG. 82 shows the shield 200 in the unexpanded configuration and the tab 230 formed integrally therewith. In another variation, the tab 230 is a separate element attached to the first end 202 of the shield 200 by adhesive, staples or other fasteners. In yet another variation, the tab 230 has a tether attached to the shield 200, and in another variation, the tab 230 is a tether and is not an extension of the shield 200.

83 and 84, the shield 200 is shown with a lock 234. The lock 234 is configured to lock the lateral or diametric dimension of the shield 200 while the shield 200 is in the unexpanded configuration. When the shield 200 is in place, the forces of the surrounding tissue may cause the lateral or diametric dimension of the shield 200 to be smaller than desired. While the shield 200 may have a relaxed normal configuration while in the unexpanded configuration, the built-in bias of the shield 200 may not be sufficient to overcome the forces of the surrounding tissue or may not be to the surgeon's preference for a particular procedure, or for a particular instrument to be passed through the central lumen 216, or for a particularly large specimen of target tissue. In either case, the lock 234 is configured to lock the shield 200 to hold its lateral or diametric dimension substantially fixed, and in particular to prevent reduction in the lateral or diametric dimension due to forces from the surrounding tissue. For example, if the shield 200 is to be inserted into an incision or body opening that is relatively smaller than the lateral dimensions of the shield 200, the shield 200 is first reduced to a compact configuration, such as that shown in FIG. 81. While in the compacted configuration, the shield 200 is inserted into the wound or body opening. The force of the surrounding tissue in response to the shield 200 in the inserted state should be greater than the bias that tends to return the shield 200 to its normal configuration in an unstressed relaxed state. In such a case, the surgeon may desire a larger central lumen 216 for the shield 200 or to retract the surrounding tissue. The surgeon then expands the shield 200 into the larger lateral or larger diameter configuration and locks this position with the lock 234 directed at the shield 200. In one version, the lock 234 has a first notch 236 located a proximal distance from the first inner end 202 of the shield 200 and near the apical end 212 and a second notch 238 located a proximal distance from the second outer end 204 of the shield 200 and near the apical end 212. The notches 236, 238 are located near where one end 202 of the shield 200 overlaps with the other end 204 of the shield 200 in the unexpanded configuration. The shield 200 is shown in the unlocked configuration in FIG. 83. To lock the shield 200, the shield 200 is expanded in the lateral dimension by spreading the shield 200 to form the large diameter central lumen 216. The first notch 236 overlaps the second notch 238 to lock the shield 200 in a fixed diametric/lateral dimensional position, while the remainder of the shield 200 maintains some degree of circumferential overlap around the circumference of the shield 200. FIG. 84 shows the first notch 236 overlapping or interlocking with the second notch 238 in the locked configuration. While in the locked configuration, at least a portion of the first end 202 is outside at least a portion of the second end 204, such that a portion of the inner surface 208 of the first notch 236 faces the outer surface 210 of the second notch 238. To unlock the shield 200, the notches 236, 238 are disengaged from one another.

As described above, the shield 200 may be inserted into the wound or body opening by rolling and/or squeezing the shield 200 to a small diameter and then inserting it into the wound or body opening. Insertion of the shield 200 can be easily accomplished with common surgical instruments, such as clamps or graspers. Once inserted, the shield 200 will naturally open slightly and the tissue will flex to collapse out of its configuration. In one variation, the shield has a lock 234 that can lock the shield 200 at a slightly larger diameter where it naturally closes. The lock 234 has notches 236, 238 along the outer edge of the shield 200 near the first and second ends 202, 204 where the coiled material overlaps. The notches 236, 238 overlap each other in the locked configuration, so that at least a portion of the inner end of the shield 200 snaps out of the outer end of the shield 200. The exposed tabs of the lock 234 are pinched into an overlapping position that provides a mechanical interlock.

85 and 86, another variation of the lock 234 on the shield 200 is shown. The lock 234 has interlocking teeth. Specifically, a first set of external teeth 240 is formed on the outer surface 210 near the first inner end 202 of the shield 200, and a second set of internal teeth 242 is formed on the inner surface 208 near the second outer end 204 of the shield 200. The first set of external teeth 240 extend substantially vertically and are recessed near the first inner end 202. The second set of internal teeth 242 extend substantially vertically and are recessed near the second outer end 204. The external teeth 240 and internal teeth 242 may also be oblique. In one variation, the teeth 240, 242 are angled so that they can easily slide or rub against each other as they move from the reduced lateral dimension to the increased lateral dimension. The angle of the teeth locks the ends together and prevents the shield 200 from shrinking laterally due to tissue forces at the wound or body opening. The external teeth 240 and the internal teeth 242 are configured to interlock with each other to prevent the shield 200 from shrinking in the lateral dimension. A plurality of internal teeth 242 and a plurality of external teeth 240 are formed along at least a portion of the circumference near the first and second ends 202, 204 so that the location where the shield 200 is locked can be adjusted as needed, thus fixing the lateral dimension as desired. Although the teeth 240, 242 are shown in a vertical midline relative to the longitudinal axis 218, the invention may have teeth located anywhere along the vertical direction.

In another variation of the lock on the shield 200, the shield 200 includes a protrusion extending from an inner surface. The protrusion may be shaped like a hook and may be configured to mate with a notch or opening in an adjacent portion of the shield 200. In one variation, the protrusion is located near one of the first inner end 202 and the second outer end 204, and the notch or opening is formed near the other of the first inner end 202 and the second outer end 204.

The shield 200 protects tissue surrounding a wound or body opening from sharp objects, such as blades and morcellators, during surgery. The terms wound, body opening, incision, and body opening are used interchangeably herein. A wound is generally a minimally invasive incision made through the abdominal wall for laparoscopic or other types of surgery. In an expanded configuration, the shield 200 is a spiral spring made of a ribbon of material formed into a spiral that exerts an outward force when inserted into a wound or body opening. The shield 200 also retracts tissue within the wound or body opening and provides an opening across the abdominal wall or through the body opening via a central lumen 216, which is generally circular in shape when viewed along a longitudinal axis 218. In one variation of the shield 200, the shield 200 is made by winding a generally flat ribbon of material into a cylindrical or conical shape, without any curves. In another variation, the curved ribbon shield 200 has a C-shaped vertical profile when viewed from the side. The proximal and distal edges, also referred to as the apex 212 and base 214 ends, are larger in diameter than the intermediate portion of the shield 200 forming the apex flange 222 and base flange 224, respectively. This C-shaped configuration advantageously contains tissue at the wound opening and provides an anchor-like fixation means so that the shield 200 does not easily axially disengage from the wound or body opening during normal use. In one variation, the C-shape is a parabola as shown in FIG. 75. The apex of the parabola lies in a plane perpendicular to the longitudinal axis 218. In another variation, the apex lies between the apex 212 or base 214 ends and the vertical midline.

Removal of the shield 200 from the wound or body opening is accomplished by first disengaging the interlocking features 234 from one another, grasping the exposed inner corners of the shield 200 and curling it inward in the spiral direction of the material, then pulling it upward along the longitudinal axis and out of the wound or body opening. The shield 200 advantageously spirals into a helical configuration in the expanded configuration. The shield 200 can be withdrawn with the fingers of a hand or with a common surgical instrument, such as a clamp or grasper. One variation of the shield 200 is made of a cut-resistant, yet flexible, plastic material. The material selection and thickness provide the protective features. The shield 200 is flexible enough to be inserted and removed, yet rigid enough to remain secured and provide protection.

The shield 200 provides several advantageous features. One important feature provided by the sheet 200 is that it protects the surrounding tissue from sharp objects such as blades, scalpels and morcellators. The shield 200 also provides protection for the containment bag in which it is housed, preventing the containment bag from being pierced or cut by sharp objects, thereby maintaining containment of the biological specimen with reduced risk of leakage. The top flange 222 provides a broad noble or cut-plate-like protection for the tissue, with the bag surface surrounding the wound or body opening. The top flange 222 overlies, covers and/or protects the tissue margins and/or the containment bag. The middle portion of the shield 200 also shields the tissue at the wound or body opening and, if a containment bag is used, protects the containment bag in which it is housed. Additionally, the intermediate portion advantageously allows the surgeon to use the blade to reach deep to cut tissue specimens near the mid-horizontal plane perpendicular to or above the longitudinal axis, and to reach distally beyond the mid-plane of the shield 200 to cut tissue specimens, since the entire vertical length of the shield 200 provides protection to the surrounding tissue and containment pouch.

Another advantage of the shield 200 is that it has an anchoring feature. The shield 200 is advantageously configured to anchor itself within the wound and body opening with a C-shaped design. The anchoring feature dramatically simplifies and speeds up the morcellation procedure since it does not require sutures or a second hand to hold the shield 200 in place during the normal procedure. Dual flanges (top and bottom 222, 224) are provided to anchor the shield 200, thereby capturing the tissue or abdominal wall within the C-shaped recess. The shield has a distal anchoring member for positioning within the wound and a proximal anchoring member for positioning outside the wound opening. A single flange, whether a top or bottom flange, is also within the scope of the present invention. Additionally, while the top flange 222 and the bottom flange 224 are shown as extending along the entire circumference of the top end 212 and the bottom end 214, respectively, the invention is not so limited and one or more of the top and bottom flanges 222, 224 may extend around at least a portion of the circumference. In such a variation, finger-like extensions may be formed in place of the circumferential bottom flange 224. The fingers may be easily deflected along the length to allow for easy insertion and then spring radially outward to a resting position below the abdominal wall or other tissue structure or body opening. Additionally, the top flange 222 may extend radially outward a greater distance than the bottom flange 224, as shown in FIG. 79, or vice versa, to provide a wider cutting surface.

Additionally, the shield 200 is advantageously adapted for easy insertion and removal from a wound or body opening. The shield 200 has a vertically expanded and vertically unexpanded (unexpanded) configuration that provides the shield 200 with vertical flexibility. This allows for easy removal of the shield 200 by simply pulling one end of the shield 200 proximally, causing the shield 200 to spiral out of the mated unexpanded configuration and into an expanded spiral configuration, free of adjacent and overlapping flanges and/or recesses. Tabs, holes, and/or tethers 230 are provided to assist in grasping and pulling the shield 200 vertically. Additionally, while in the mated or unexpanded configuration, the shield 200 can be moved to a compact configuration by wrapping or curling the shield 200 on itself to form a small or tight circle and forming more convolutions around itself. The shield 200 is advantageously moved from the compacted configuration laterally by releasing the compacted configuration, where the shield then assumes a normal relaxed configuration having a relatively large lateral dimension. Another expanded configuration may also be provided by the shield 200, in which a lateral or diametric position larger than the normal or relaxed configuration may be locked in place by a lock 234 formed on the shield 200. The lateral flexibility of the shield 200 may reduce the lateral dimension, thereby allowing for easier insertion into a wound or body opening. Also, from the locked increased diameter position, the shield 200 may be unlocked to reduce the lateral dimension, thereby facilitating removal from a wound or body opening, by simply unlocking the shield 200 and/or by unlocking the shield 200 and then curling itself into a tightened configuration.

The shield 200 is also advantageously self-deploying. After curling the shield 200 into a compacted lateral configuration, it is easily inserted into a wound or body opening and then released, whereupon the shield tends to expand in size due to its spring bias. This lateral spring-back action helps the shield 200 to automatically snap into the wound or body opening with little effort, while at the same time providing protection and retraction to the tissue and/or containment pouch, thereby keeping both away from sharp objects that may be encountered during a typical procedure.

Additionally, while in the vertically unexpanded configuration, the shield 200 has an overall outer diameter that is C-shaped or hourglass-shaped, where the proximal end flares radially outward from the longitudinal axis, and the distal end of the shield 200 flares radially outward from the longitudinal axis, with the waist being the narrowest lateral dimension along a plane between the proximal and distal ends of the shield. The flare at the distal end of the shield 200 advantageously provides a bevel or funnel that facilitates guiding and moving the target tissue into and through the shield 200.

The flexibility of the shield 200 allows it to be easily inserted, deployed, removed, and anchored due to expansion. Flexibility is advantageously balanced against the ability to provide protection to the surrounding tissue and/or containment bag. When properly implemented, the protection provided by the shield 200 is sufficient for manual morcellation procedures while allowing the surgeon the freedom to use personal morcellation techniques. The shield 200 is inserted into the mouth of the containment bag, which can also be placed in the neck of the containment bag or in the main container of the containment bag. The containment bag surrounds the shield 200, which is captured between the tissue/body opening and the shield 200. The shield 200 helps to retract the surrounding tissue as well as the surrounding containment bag material. The shield 200 exerts sufficient force on the containment bag to keep it in a substantially fixed position so that it does not slide into the wound or body opening. A sufficient amount of the proximal end of the bag is positioned proximal to the shield and over the patient's exterior surface, e.g., abdomen, thereby forming a blanket to help prevent contamination. The shield 200 is configured to hold the mouth of the containment bag in an accessible open configuration and to receive and support a manual or powered morcellation device.

In another variation, the shield 200 is adapted to be inserted into the vaginal canal and is therefore long in length as shown. The shield 200 may further include a shape memory portion to aid in deployment. The shield 200 allows for reliable and safe removal of endogenous samples and is easy to use, thereby reducing surgical time and costs. The shield 200, in combination with a containment bag, helps reduce the risk of contamination of healthy tissue with potentially malignant cells during tissue sampling and removal procedures.

54-59, the pouch 310 of the present invention will now be described. The pouch 310 has a single opening or mouth 312. A semi-rigid compressible plastic ring 314 is coupled to the pouch 310 at or near the pouch mouth 312. The ring 314 is compressible from a round or large configuration to an oval or small configuration so that the pouch 310 can be inserted through a small incision. Once placed in the patient's body, the elastic ring 314 expands to its original uncompressed large configuration, thereby opening the mouth 312 of the pouch 310 with it. When placed flat in the patient's body, the ring 314 clearly defines the mouth 312 of the pouch 310, and the opening 312 may be difficult to see under laparoscopic observation without the ring 314. In some cases, the opening 312 of the pouch 310 may be difficult to find. The opening 312 must then be oriented within the patient's body so that the tissue is clearly placed within the opening 312 and not beyond it. In the present invention, the expanded ring 314, when placed on top of the pouch 310, allows the tissue placed within the ring 314 to settle within the pouch 310 when the ring 314 is lifted toward the incision. An empty pouch 310 lies flat on a flat surface and the ring 314 naturally falls above the pouch 310. The elastic ring 314 allows the pouch 310 to remain open without assistance within the abdominal cavity, thereby facilitating tissue capture.

After the tissue sample is placed in the ring 314, the ring 314 is pulled up towards the incision. A tether 316 is provided near the mouth 312 of the bag 310 to assist the surgeon in pulling the bag 310 up towards the incision. The tether 316 may have a tag 318 located at its proximal end, which remains outside the patient's body when the bag 310 is placed inside the patient's body. The tag 318 is also easily found inside the patient. The large tag 318 helps to quickly locate the tether 316 and pull it if necessary. The tether 316 may also be configured to pull the bag 310 closed, in order to prevent the contents of the bag 310 from spilling out. Alternatively, an additional drawstring may be provided connected to the bag 310 and located under or above the ring 314, so that the drawstring closes the bag circumferentially. Other ways of closing or sealing, such as a pressure fit or zipper, may also be provided.

As the sack 310 is pulled and positioned near the incision, it compresses the ring 314 from its expanded form to its compressed form so that the ring 314 can be pulled through the small incision. The ring 314 is compressed using a grasper or manually through the incision opening. After the ring 314 is pulled through the incision, a sufficient amount of the sack 310 is pulled with the ring so that it rests on and covers a portion of the patient's abdomen. Therefore, the sack 310 must be large enough to create an apron effect around the incision outside the patient's body. With the ring 314 and a portion of the sack 310 outside the patient's body, the remainder of the sack 310 and the tissue specimen remain located inside the patient's body.

The cross section of the ring 314 may be circular, with a hollow center to provide flexibility. In one variation, the ring 314 may be elliptical, elongated or oval in cross section. In the variation shown, the ring 314 has a shape resembling a figure eight or having two interlocking circular cross sections, resulting in a small valley 320 between the circles. Generally speaking, the cross section of the ring 314 has a length greater than its width. This elongated cross section allows the ring 314 to be turned or turned over on itself by turning the ring 314 outwardly or inwardly and rolling the bag 310 over on itself. Rolling the ring 314 in the opposite direction allows the bag 310 to unroll from the ring 314. The elongated cross section of the ring 314 advantageously keeps the side walls of the bag 310 rolled over the ring 314. If the cross section is circular, the ring 314 can easily be rolled on itself, thereby unrolling the rolled sidewall of the bag 310. The rolling of the ring 314 on itself pulls the bag 310 upward and brings the specimen within the bag 310 closer to the incision opening. The rolling action of the bag 310 reduces the bulk of the bag 310 located inside the patient's body, yet creates a precisely formed, taut apron outside the patient's body. If the bag 310 is retracted too tightly, the ring 314 may bend. The tissue specimen is then extracted from the bag 310 by morcellating it with a blade or electronic morcellator into a size and shape that can pass through a small incision and be removed from the bag 310. The sidewall 328 of the bag 310 can be rolled on itself to form a roll 330 that is located adjacent to the ring 314 to facilitate deployment as shown in FIG. 59. Squeeze ring 314 so that the compressed length of ring 314 aligns with the length of roll 330 to allow for easy insertion.

55 and 56, the ring 314 is formed of a single strip 322 of plastic that is shaped into a circle or other shape by joining the free ends together. In another variation, the ring 314 is made of two or more pieces, such as two semicircles, that together form a circle of the same radius. The ends are not connected to each other and are held in a normal curved configuration within a sleeve at the mouth of the bag 310. The multi-piece ring 314 facilitates compression of the ring 314 into a small configuration. The ring 314 is approximately 0.38 inches (9.65 mm) high, 0.18 inches (4.57 mm) wide, and approximately 38 inches (96.52 cm) long. The thickness of the material forming the ring 314 is approximately 0.18 inches (4.57 mm).

57-59, the bag 310 is made from a single sheet 324 of material. The sheet 324 of material is folded lengthwise and heat sealed at the sides to form a seam 326. The weakest part of any bag 310 is the area around the welded seam 326. As can be seen in FIG. 57, there is no welded seam 326 at the bottom of the bag 310 where the forces during specimen removal may be most concentrated, thereby giving the bag 310 a large critical strength. The material of the bag 310 is also made from a 4.2 mil Inzii® film that is clear and allows the surgeon to see through the sides of the bag 310 during surgery. Being able to see through the bag 310 eliminates the need to puncture the sides of the bag 310 to achieve visualization. The film is elastic and provides good retraction for the bag 310. The bag 310 may also be made of U-5746 rip-stop nylon with a polyurethane coating. The polyurethane coating makes the film airtight and heat sealable. U-5746 is a military grade material that is stronger than Inzii® film but has less retraction and is opaque. The bag 310 is approximately 16 inches (40.64 cm) long and 12 inches (30.48 cm) wide at the mouth 312. The bottom of the bag 310 forms an angle of approximately 45° with the side wall 328 at a distance of approximately 12.4 inches (31.50 cm) from the mouth 312. The bag 310 has a thickness of approximately 0.2 inches (5.10 mm) and at the seam 326 the bag 310 is approximately twice as thick. In another variation, the bag 310 is double-bagged, one bag located inside the other to provide greater resistance to accidental puncture. In another variation, only the bottom portion of the bag 310 is reinforced with a double-walled construction. The bag 310 is leak-proof and prevents the entry of viruses.

As mentioned above, a shield may be provided for use in conjunction with the bag 310. After the bag 310 is placed in the patient and pulled through the incision, the shield is inserted into the mouth 312 of the containment bag 310. The shield is made of thick plastic and protects the plastic bag 310 from being accidentally cut by the blade used by the surgeon to morselize the target tissue. The shield may also serve as a cutting plate, allowing the surgeon to cut the target tissue against the cutting plate if necessary. The bag 310 may also be used with a retractor as described above, where as the bag 310 is pulled through the incision, the retractor is placed into the mouth 312 of the bag 310 to retract the tissue and bag 310 at the incision site, and then the shield is placed into the retractor to remove the specimen.

60-63, a bag introducer or fork 410 is used to introduce the containment bag 310 through a small incision into a patient's body cavity. The introducer 410 facilitates placement of the bag 310 into the surgical field. The fork 410 has a proximal end 412 and a distal end 414. A handle 416 is provided at the proximal end 412. A first branch 418 and a second branch 420 extend distally from the handle 416 to form a substantially fork-like configuration. The branches 418, 420 are of equal length. The branches 418, 420 can have any suitable cross-section, and the branches are spaced a sufficient distance apart. The branches 418, 420 are made of stainless steel and are connected to an injection molded plastic or metal handle 416 as shown in FIG. In this design, a steel rod with tines 418, 420 is inserted into and connected to an injection molded handle 416, which allows for a fork 410 with a small profile, but is expensive and time consuming to manufacture. In FIG. 61, the fork 410 is made from a single piece of material, where both the handle 416 and tines 418, 420 are injection molded to form a one-piece structure. This design is the easiest and least expensive to manufacture, at the expense of a large profile and a weaker design.

In use, and with particular reference to Figs. 62 and 63, the bottom of the containment bag 310 is placed between the tines 418, 420 with the tether 316 and tag 318 positioned near the handle 416. The bottom edge of the bag 310 is folded back over the tines 418, 420 with the tines 418, 420 extending slightly beyond the end of the bag 310. Thus, the tines 418, 420 are slightly longer than the width of the bag 310. The handle 416 is grasped and turned, thereby allowing the bag 310 to be evenly rolled into the tubular roll 330 until resistance is felt. The bag 310 is reduced to the smallest size possible for introduction into the body region. The elastic ring 314 is squeezed to roll the bag 310 until it is taut and positioned next to the ring 314. With visualization possible, insert the sack 310 and fork 410 combination through the incision so that the opening 312 of the ring 314 is positioned upwards. Insert the sack 310 until it is about 3/4 way into the incision. Rotate the fork 410 back to loosen the sack 310 slightly. Loosening the sack 310 reduces tension on the sack, which makes it easier for tissue to fall into the sack 310. The fork 410 allows the sack 310 to be easily deployed while controlling how tightly the sack 310 is rolled and the direction of the ring opening 312 during insertion. If the sack 310 is rolled too tightly, tissue will not easily fall into the sack 310 even if the ring 314 is lifted up inside the patient. Rotating the introducer 410 back before removing it will make it easier to insert tissue into the sack 310.

The fork 410 is released from the bag 310 by pulling the handle 416 proximally. The remaining quarter of the bag 310 is pushed into the incision. After the bag 310 is fully deployed in the abdominal cavity, an access port and scope are placed and the cavity is insufflated. The bag 310 is positioned so that the ring 314 is on top of the bag 310. The access port may be placed in the same incision or a secondary incision. With visualization available, the tissue to be morcellated and removed from the patient is placed into the bag 310. A lateral access port may be used to visualize and confirm that tissue is present in the bag 310. The access port is removed and removal of the bag 310 outside the patient begins. The secondary access port does not need to be removed and may be used to continue viewing the removal and next morcellation. The tag 318 may be located outside the patient. The tag is pulled to pull the bag 310 up towards the incision. If the tag 318 is present within the body cavity, a grasper can be used to grasp the tag 318 with visualization through the access port. The tether 316 and tag 318 are pulled up through the incision until a portion of the ring 314 is through the incision. The ring 314 is pulled until the entire ring 314 is outside the incision. The pouch 310 is retracted by rolling/turning the ring 314 over itself and wrapping the pouch 310 around the ring 314. This rolling of the ring 314 not only retracts the tissue slightly, but also reduces the bulk of the pouch 310 within the patient, thereby drawing the tissue closer to the surface within the patient. The tissue is then morcellated.

Alternatively, a retractor with a central lumen is placed into the mouth of the bag 310 at the incision, and the tissue is retracted together with the bag 310, thereby widening the opening, and then the tissue is morcellated with the bag 310 in place. A retractor with a central lumen is placed into the mouth of the bag 310 at the incision, and a shield as described above is prepared and used in conjunction with the bag 310 and the retractor. The shield is placed into the central lumen of the retractor. Of course, the shield can be used without the retractor. If a retractor is not used, the shield is placed into the mouth 312 of the bag 310 at the incision. The shield is inserted into the mouth 312 of the containment bag 310 after the bag 310 is placed inside the patient's body and pulled through the incision. The shield is made of thick plastic, which protects the plastic bag 310 from being accidentally cut by the blade used by the surgeon to morcellate the target tissue. The shield may also serve as a cutting plate, allowing the surgeon to cut the target tissue against the cutting plate if necessary. The shield itself may also function as a retractor, with a first, reduced dimension and a second, enlarged dimension. The second, enlarged dimension serves to retract the tissue.

When a retractor is used within the pouch 310, the retractor advantageously not only retracts the tissue, but also retracts a portion of the pouch, thereby keeping the pouch away from the morcellation blade, thereby protecting the pouch from nicks and perforations. A typical retractor has a top ring and a bottom ring with a flexible side wall connected between them. The bottom ring is inserted through the incision, with the bottom ring located inside the patient, while the top ring of the retractor is located above the patient. The top ring rolls/turns over on itself like a pouch, drawing the lower ring of the retractor closer and bringing the side walls into a taut relationship between the rings. The lower ring of the retractor advantageously retracts the portion of the pouch 310 inside the patient to avoid potential damage caused by puncturing and tearing by the blade.

The tissue is morcellated in the manner desired by the surgeon. Generally speaking, a small portion of the target tissue is extracted from the patient while the majority of the target tissue remains within the patient. The surgeon takes the blade and makes approximately 180° or 360° circumferential cuts around the circumference of the protruding tissue without severing the protruding tissue from the remainder of the target tissue. By keeping the protruding tissue intact with the larger pieces remaining within the patient, the surgeon can continue to grasp the tissue without losing track of the tissue within the pouch. The surgeon pulls the grasped tissue out of the patient in small increments, making periodic circumferential cuts of any size to extract more of the tissue until the entire piece of target tissue is removed. The result is a single elongated piece of the target tissue that is removed rather than multiple small pieces. If not removed as a unit, the target tissue is removed in several small pieces and in a more controlled manner. The pouch 310 can be further retracted between cuts, thereby bringing the specimen closer to the surface. Once the tissue remaining in the pouch 310 is small enough to easily pass through the incision, the pouch 310 is completely removed.

64 and 65, another shield 510 of the present invention is shown. The shield 510 has a first ring 512 located at a proximal end 514 and a second ring 516 located at a distal end 518. The rings 512, 516 are substantially parallel to one another and are connected to one another by a sidewall 520. The sidewall 520 is a woven sheath material that can be made of soft fibers or polymers. This material can be Kevlar®, Dyneema®, rip-stop nylon, or a polymer blend material. The sidewall 520 is heat sealed or bonded to the rings 512, 516. The first and second rings 512, 516 are semi-rigid and compressible between a normal high profile large configuration and a compressed low profile elongated configuration. The rings 512, 516 are generally circular in their normal configuration, but may be elliptical. The rings 512, 516 can be compressed from a round or large configuration to an oval or small configuration so that the shield 510 can be inserted into a small incision, particularly into the mouth of a containment bag to protect the shield. In one variation, only the second ring 516 is compressible for insertion into the incision, and the first ring 512 is rigid so that the first ring 512 is located externally or proximally relative to the patient's body. The rigid proximal first ring 512 can be large and wide to act as a large shield or cutting plate for morcellation. The second or distally located ring 516 is flexible and suitable for being compressed and easily inserted into a bag, and can be slightly smaller in diameter than the first ring 512.

One or more of the rings 512, 516 may have a circular cross section. The rings 512, 516 have a hollow center to provide flexibility. In one variation, the rings 512, 516 have an elliptical, elongated or oval cross section with a hollow center. In another variation, the rings 512, 516 have a shape resembling a figure eight with two interlocking circular cross sections, as shown in Figures 55A and 55B, resulting in a small valley between the circles. Generally speaking, the cross section of the rings 512, 516 has a length greater than its width. This elongated cross section allows each ring 512, 516 to be turned or flipped over itself by flipping the rings 512, 516 outwardly or inwardly and wrapping the sidewall 520 around the rings 512, 516. In one variation, only the first or proximal ring 512 is configured to wrap the sidewall 520 around the rings 512, 516. In another variation, both rings 512, 516 are configured to wrap the shield 510 in two directions, i.e., either the first ring 512 or the second ring 516 can be positioned proximal to the incision/body opening and can be wrapped. The shield 510 is inserted by compressing one or more of the rings 512, 516. Both rings 512, 516 can be compressed to a low profile configuration that allows easy insertion through the incision, but generally speaking, only the distal ring needs to be compressed, while the proximal ring, which is located outside the patient's body, does not need to be compressed. Also, only the proximal ring needs to be configured to wrap the side wall 520 when the distal ring is located inside the patient's body. One or more of the rings 512, 516 that are configured to wrap can be wrapped in the opposite direction to increase the length of the side wall 520. Rolling one of the rings 512, 516 rolls the length of the sidewall 520 onto the ring, thereby shortening the length of the shield 510. The elongated cross-section of the ring advantageously keeps the sidewall 520 rolled round on the ring. If the cross-section were circular, the ring could be easily rolled in the field, thereby unrolling the rolled sidewall 520. The rolling of the ring on itself pulls the opposite ring upward toward it.

The rings 512, 516 are made of a single elongated plastic piece formed into a circle or other shape by joining the free ends together. In another variation, the rings 512, 516 are made of two or more pieces, such as two semicircles that together form a circle for each ring. The ends are not connected to each other and are held in a normal curved configuration. The multi-piece rings make it easy to compress the rings into a small low profile configuration. The rings are about 0.38 inches (9.65 mm) high, 0.18 inches (4.57 mm) wide, and about 38 inches (96.52 cm) long. The thickness of the material forming the ring 314 is about 0.18 inches (4.57 mm). FIG. 65 shows the shield 510 retracted by placing the first ring 512 in the pouch 310 and rotating the proximally located first ring 512 on itself until the proximal rigid ring 512 is flush with the patient's outer surface or abdomen. The cut-resistant material of the rings 512, 516 and sidewall 520 protects the pouch 310. Retraction by rolling the proximal first ring 512 advantageously lengthens the incision. The resulting larger incision significantly facilitates manual morcellation. In another variation, the shield 510 is not configured to allow rolling of one or more of the rings 512, 516 to reduce the length of the shield 510 and the sidewalls of the shield 510 that are made of the protective material.

66 and 67, an alternative shield 510 of the present invention is shown. The shield 510 is similar to the shield of FIGS. 64 and 65 in that it has a first ring 512 located at a proximal end 514 and a second ring 516 located at a distal end 518, which are connected to one another by a flexible sidewall 520. The modified sidewall 520 shown in FIGS. 66 and 67 has a first layer 522 and a second layer 524, which are shown separated and laid flat in FIG. 67. The first layer 522 has a plurality of vertical slits 526 and the second layer 524 has a plurality of vertical slits 528. The first layer 522 is positioned adjacent or juxtaposed to the second layer 524 to form a lantern-shaped sidewall 520, with the slits 526 in the first layer 522 and slits 528 in the second layer 524 offset from one another so that they do not join to form a breach through the shield 510. In contrast, the overlapping layers 522, 524 with the offset slits 526, 528 form a flexible yet strong sidewall 520 that resists penetration. Each of the first layer 522 and second layer 524 is a flexible or semi-flexible sheath that is easily bent yet cut-resistant. The layers 522, 524 are flexible enough to facilitate insertion yet be retractable upon placement into a pouch located within an incision, with or without eversion of the rings 512, 516 as described above. In another variation, the slits 526, 528 are not perpendicular to the top and bottom edges of the layers 522, 524 as shown in FIG. 67. Instead, the slits 526, 528 are angled relative to the top and bottom edges. The overall height of the shield 510 is about 0.5-2.0 inches (1.27-5.08 cm), and the sidewalls 520 are made of a protective material.

Now referring to Figures 68-70, another variation of the present invention, a shield 530, is shown. The shield 530 is made of a soft or semi-rigid plastic. The shield 530 has a flange 532 that is substantially flat and has an opening 534 in the middle. Looking at the opening 534, a number of slits 536 extend outwardly from the periphery of the opening 534 into the flange 532, thereby increasing the flexibility of the corner intersection. The flange 532 is sized and shaped to fit within the retractor when the retractor is used. Specifically, the flange 532 snaps under the top ring of the retractor to help hold the shield 530 in place.

The flange 532 is connected to a central tubular section 538. The tubular section 538 has a central lumen extending between an opening 534 at the proximal end and an opening 540 at the distal end. The tubular section 538 may further have a plurality of slits 542 extending upward from the distal opening 540. The shield 530 further has two fingers or elongated extensions 544 that extend downward from the tubular section 538 at an oblique angle that constitutes a first configuration for the fingers 544. The fingers 544 have a second configuration that is a reduced or compressed configuration as shown in FIG. 69, in which the fingers 544 are pressed together or folded back toward the longitudinal axis to assume a lateral dimension that is the same as or smaller than the lateral dimension of the central tubular section 538. The reduced configuration facilitates insertion of the shield 530 into an incision or body opening. When inserted across the abdominal wall as shown in FIG. 70, fingers 544 are advantageously configured to spring back into a first configuration in which fingers 544 flare outward at an angle. In this first configuration, within the incision, fingers 544 advantageously not only retract tissue but also retract the pouch (not shown) into which it is inserted. Slits 542 provide additional flexibility to the distal end of central portion 538, allowing central portion 538 to assume a narrow configuration when placed in the incision and then spring back into its normal configuration, which aids in pouch and tissue retraction. The height of flange 532 and central portion 538 is approximately 0.5-2.0 inches (1.27-5.08 cm), and shield 530 is made of HDPE, LDPE, HYTREL® or other suitable polymer or metal. Additionally, the shield 530 may have three or more fingers 544.

Referring now to Figures 87-90, a morcellation system 600 is shown. Morcellation system 600 is an instrument that allows for the safe removal of bodily tissue or organs en bloc through a restricted surgical opening. Morcellation system 600 is a substantially closed system that prevents contamination of surrounding tissue with potentially cancerous cells present in the target tissue during the morcellation and extraction procedure. Morcellation system 600 includes a morcellator 602, a containment bag (not shown), a tenaculum 606, and a shield 608.

The containment bag may be any of the bag embodiments described herein. Generally speaking, the containment bag comprises a polymer pouch with a mouth or opening attached to a ring that surrounds the mouth or opening. The ring is flexible and configured to be biased into an open configuration such that the mouth of the bag is held open by the ring to facilitate insertion of the specimen into the bag. The ring is flexible such that it can be compressed to a low profile state, thereby allowing it to be easily inserted into a wound or body opening. The ring remains open such that the bag can be retracted by rotating the ring on itself and wrapping the side walls of the bag around the ring. A tether is attached to the ring or to the proximal end of the bag. The tether has an attached tag that can be grasped by a surgical instrument.

The morcellator system 600 further includes a morcellator 602. The morcellator 602 is a powered morcellator. The morcellator 602 has a cutting ring or annular blade 610 with a sharp distal end adapted to cut tissue. The annular blade 610 is attached to a hollow barrel 612. The barrel 612 is connected by gears to a pneumatic or electric motor (not shown) for rotation about a longitudinal axis. The morcellator 602 has an inner barrel 614 with a flared or funnel-shaped proximal end connected to a morcellator housing 616. The distal end 620 of the inner barrel 614 extends to a location proximal to the annular blade 610. The inner barrel 614 defines a working channel or central lumen 618 of the morcellator 602. The inner barrel 614 prevents tissue drawn into the central channel 618 from rotating within the morcellator 602. The morcellator 602 further includes an outer barrel 622. The outer barrel 622 coaxially surrounds the cutting barrel 612. The outer barrel 622 has a proximal end that is connected to or is part of the housing 616. The distal end 624 of the outer barrel extends to a location proximal to the distal end of the blade 610. The outer barrel 622 has an extension 626 located at the distal end 624 of the outer barrel 622. The extension 626 extends slightly beyond the distal end of the blade 610. The extension 626 prevents coring of the morcellated specimen.

The morcellation system 600 further includes a shield 608. The shield 608 may be any of the shields described herein, and in one variation may be the shield described with reference to FIGS. 51-53 and 71-86. The shield 608 has an overall spiral shape when viewed in a vertically extended configuration. The shield 608 is collapsible to a low profile unextended configuration. The shield 608 may be moved from the extended configuration to the unextended configuration and from the unextended configuration to the extended configuration repeatedly as needed. The shield 608 is a soft plastic band in the shape of a spiral in the extended configuration. The shield 608 may be made of a thin soft metal or other suitable material that prevents sharps from penetrating the shield 608. The band extends between a first end and a second end and between a top or proximal end 628 and a bottom or distal end 630. The distance between the proximal end 628 and the distal end 630 is approximately the entire length 638 of the shield 608 while in the unexpanded or low-profile configuration. The shield 608 has an inner surface 632 and an outer surface 634 connected to one another by the proximal end 628 and the distal end 630 and the first and second ends. The outer surface 634 is concave and the inner surface 632 forms a conforming surface that is convex when viewed from within the shield 608. The outer surface 634 is substantially parallel to the inner surface 632. The shield 608 includes a central lumen 636. When in the low-profile unexpanded configuration, the shield 608 can be reduced in size laterally such that it has a relatively small lateral dimension. As described above, while in the low-profile unexpanded configuration, the shield 608 has a relaxed normal position with a first lateral or diametric dimension. The shield 608 also has a reduced configuration while in the low-profile unexpanded configuration having a second lateral or diametric dimension. The second lateral or diametric dimension is smaller than the first lateral or diametric dimension. The contracted configuration when in the unexpanded configuration is achieved by curling the shield 608 on itself into a tight and small configuration. This curling action reduces the size of the central lumen 636. This contracted configuration is held fixed by hand or by a lock. Insertion of the shield 608 into a small incision or body opening is greatly facilitated by curling the shield 608 on itself into the contracted configuration. Then, upon insertion into the incision or body opening, the shield 608 is released to expand from the tight curled state toward a relaxed normal position having a large lateral dimension. However, forces from the surrounding tissue can prevent the shield 608 from reaching the first lateral or diametric dimension, and thus the shield 608 can reach a dimension equal to the second lateral dimension or equal to the first lateral dimension or have any dimension between the first and second lateral dimensions. Additionally, the shield 608 can expand into an expanded configuration with a third lateral or diametric dimension. The third lateral or diametric dimension is greater than the first lateral or diametric dimension. The expanded configuration can be locked in place on the shield 608 by any of the locks described herein, which fix the position and/or lateral or diametric dimensions of the shield 608. This expanded configuration can serve to retract tissue to enlarge the opening of the body orifice or wound. The reduced configuration as well as the relaxed normal configuration and any position between the reduced and expanded configurations can serve to retract tissue to hold the wound and body orifice open while providing a working channel through the central lumen 636.

87 and 88, the morcellator 602 is shown inserted into the central lumen 636 of the shield 608. The distal end of the morcellator housing 616 abuts the proximal end 628 of the shield 608. The length 640 of the morcellator 602, including the blade barrel 612, the inner barrel 614, and the outer barrel 622, extending downward from the housing 616, is approximately equal to the length 638 of the shield 608. In one variation, the length 638 of the shield 608 is shorter than the extension 626 protruding from the outer barrel 622. FIG. 87 shows the extension 626 extending beyond the length of the shield 608. In such a variation, the distal end of the shield 608 is located just proximal to the extension 626. In another variation, the length 638 of the shield 608 is equal to the distal end of the annular blade 610. In another variation, the length 638 of the shield 608 extends slightly distally beyond the blade 610. In another variation, the length 638 of the shield 608 is distal to the extension 626. The length 638 of the shield 608 is adapted to encase the depending portion of the morcellator 602, and in particular the blade 610. By encasing the blade 610, the shield 608 protects the blade 610 from accidental contact with surrounding tissue and the containment bag.

In use, the tissue containment bag is placed through a small incision made in the abdomen or a small body orifice or opening in the body. This is accomplished by compressing the flexible ring of the bag into a low profile configuration and inserting the bag through the small incision/opening. The flexible ring springs open within the body cavity and expands the mouth of the bag, thereby facilitating placement of the cut target tissue piece into the bag. The target tissue is placed into the bag while it is located within the abdominal cavity of the body. A retractor may be used and placed within the incision. The bag's tether is then used to pull the bag's ring through the incision. The bag's ring is rolled on itself to wrap the bag sidewalls around the ring, thereby reducing the length and size of the bag, thereby drawing the specimen in the bag into the incision/opening. The specimen in the bag is visualized with the naked eye near the mouth of the bag. The shield 608 is rotated while outside the patient's body by rolling or curling it onto itself into a tight configuration to minimize its size. While in the contracted configuration, the shield 608 is placed into a pouch within the incision/opening and the shield expands on itself or diametrically to maximize the incision/opening by reversing the rotation of the shield 608. The expanded position may be secured by a lock of the type described herein. The shield 608 is stretched to its larger size. The C-shaped outer surface 634 of the shield 608 anchors well within the incision, thereby fitting the abdominal wall within the recess of the "C". The tenacious barb 606 is advanced through the central lumen 618 of the morcellator 602 and is used to grasp the target tissue while visualizing it with the naked eye. Once the tissue is properly grasped, the tissue is held by the tenacious barb 606 and the morcellator 602 is moved or slid down the length of the tenacious barb 606 until the depending portion of the morcellator 602, including the blade barrel 612, the inner barrel 614 and the outer barrel 622, passes through the central lumen 636 of the shield 608 until the distal end of the morcellator housing 616 abuts the proximal end 628 of the shield 608. The tenacious barb 606 can be pulled proximally so that the specimen contacts the blade 610 of the morcellator 602. The morcellator 602 is actuated to rotate the blade barrel 612 at high speed. With the specimen still grasped, the tenacious barb is pulled in the proximal direction. The tenacious barb is used to draw the grasped tissue into the cutting blade of the morcellator 602. The extension 626 of the outer barrel 622 prevents the entire circumference of the blade 610 from cutting through the tissue at the same time. This prevents coring and causes the blade 610 to move along the specimen, resulting in the majority of the specimen being removed in one piece. After all of the tissue has been removed or reduced to small pieces sized to fit through the incision, the shield 608 and pouch are removed. The shield 608 advantageously protects and retracts the adjacent tissue at the incision and protects the adjacent portion of the containment pouch from accidentally contacting the cutting blade 610. The present invention also avoids making a secondary opening in the containment pouch to insert a scope to visualize the morcellation procedure. Secondary openings, which would compromise a closed containment system, are advantageously avoided by this morcellation system 600. Morcellation within a body cavity can scatter potentially harmful fragments of the specimen being morcellated. Morcellation within a closed system is therefore desirable. A closed system is created by placing the specimen in a containment bag and bringing the opening of the bag through the incision to the surface, thereby isolating the specimen in the bag and preventing it from coming into contact with tissue within the body cavity. Conventional solutions for visualization require making a separate opening in the bag and placing the laparoscope through this opening, thus no longer maintaining a closed system. Alternatively, the scope may be placed through the same incision as the morcellator, resulting in poor visibility and triangulation necessary for optimal viewing. The shield 608 advantageously allows cutting mechanisms, including powered morcellators, to be used in a closed system while preventing potential damage to the contained system. The morcellation system 600 can provide visibility of the specimen without a laparoscope by bringing the specimen to the surface when the bag is retracted. The morcellation system 600 maintains and ensures a closed system throughout the morcellation procedure by reducing damage to the tissue containment bag by using the shield 608 with a corresponding short morcellator. The length of the shield 608 is approximately equal to the length of the protruding portion of the morcellator 602. The shield 608 surrounds the blade 610, which is located between the pouch and the morcellator 602. The shield 608 opens and holds the incision opening for easy visualization and removal of the specimen. The shield 608 protects the pouch and tissue at the incision site from damage by the cutting blade 610 or tenaculum 606. The outer barrel 622 of the morcellator is surrounded by the shield 608, which prevents accidental contact of the blade 610 with the containment pouch, which may result in a breach of the closed system. The shield 608 forms a protective cage around the blade to ensure safe morcellation. In one variation, the length 638 of the shield 608 in the unexpanded configuration is approximately 1 inch (2.54 cm), and the length 640 of the morcellator barrel is also approximately 1 inch (2.54 cm).

89 and 90, a morcellation system 600 is shown using an energy morcellator 602. The energy morcellator system utilizes a tissue bag, tenacitons, and shield 608 in a manner similar to that described above. Rather than rotating the blade 610 to cut the tissue, the circular blade 610 remains stationary. The blade 610 and barrel 612 of the morcellator 602 are connected to the output of a monopolar energy system 652 via an energy input 650. The tenacitons 606 are connected to a plug 654 that leads to ground on the monopolar energy system 652. Once the target tissue is grasped by the tenacitons 606 and brought to the blade 610, monopolar energy is applied to cut the tissue. The extension 626 serves the same purpose as described above. An exhaust port 656 is provided in the housing 616 to prevent inhalation of smoke from the cutting process.

91-103, a shield 700 is shown adapted to be placed within the vaginal canal. The shield 700 has a shape generally equivalent to the shields described herein. The shield 700 is substantially cylindrical/tubular in shape and is made of a band of material having an inner first end 702 and an outer second end 704 connected to one another between a proximal end 706 and a distal end 708. The shield 700 has an outer surface 710 and an inner surface 712. The inner surface 712 defines a central lumen 714 that extends from the proximal end 706 along a longitudinal axis to the distal end 708. The central lumen 714 is shown as being circular in shape, and in another variation may be elliptical or elongated oval or oblong in shape. The proximal end 706 includes a radially outwardly extending proximal flange 716 that forms a funnel-shaped entrance passage for the central lumen 714. The outer surface 634 is concave and gradually flares radially outward toward the distal end 708. At least a portion of the shield 700 overlaps itself when in a relaxed normal configuration. The shield 700 can be curled over itself to reduce a lateral dimension for ease of insertion into a vagina or other body orifice or wound incision. The overlapping portions of the shield 700 conform to one another and fit together. The shield 700 is configured to slide with one end, e.g., the first end 702, against the second end 704. The shield 700 can have a first reduced lateral or diametric dimension suitable for easy insertion into a vagina or other body orifice. The reduced lateral position is achieved by curling the shield 700 over itself to a tightened and smaller configuration. The shield 700 has a relaxed normal position with a second lateral or diametric dimension. The second lateral or diametric dimension is greater than the first lateral/diametric dimension. The shield 700 is molded with a bias toward a normal relaxed position, and when the shield 700 is contracted to a first diametric position, it automatically expands or springs open or spreads toward its relaxed and normal position having approximately a second lateral or diametric dimension. The shield 700 may be provided with a lock of the type described herein that secures the lateral or diametric position. The shield 700 further has an expanded configuration with a third lateral or diametric dimension. The third lateral or diametric dimension is greater than the second lateral or diametric dimension. The expanded configuration is achieved by curling the shield 700 in the opposite direction or spreading the shield 700 to open the central lumen 714. Any of the lateral dimension positions of the shield 700 and any intermediate positions can be locked in place with a lock. The shield 700, and particularly the expanded configuration of the shield 700, serves to retract tissue to open a body opening or wound, thereby providing a safe working channel for a surgical procedure.

As can be seen in FIGS. 93 and 94, the first end 702 and the second end 704 each have an S-shaped bend that overlaps on the outer surface 710 of the adjacent shield portion. The S-shape transitions to notches 718, 720 near the proximal end 706 and the distal end 708, respectively. The notches 718, 720 form locks configured to secure the lateral dimensions of the shield 700. The notches 718, 720 are shown in an unlocked position in FIGS. 93 and 94 and in a locked position in FIGS. 97 and 98. The notches 718, 720 form finger-like extensions configured to interdigitate with each other to lock the shield 700 in place. In FIGS. 97 and 98, the finger-like extensions located near the notches 718 of the outer second end 704 overlap with the inner first end 702 to lock the shield 700. As mentioned above, the outer surface 710 of the shield 700 forms a concave surface with an inflection point 722 visible in FIGS. 93 and 94. The inflection point 722 is located above a mid-plane perpendicular to the longitudinal axis and near the proximal flange 716. The proximal flange 716 serves as a protective surface to protect the containment pouch, retractor 724, and vaginal canal tissue at the insertion site. The shield and/or flange may be made of a hard, rigid, or semi-rigid, plastic, or cut-resistant material. The proximal flange 716, and in particular the inner surface 712 of the proximal flange 716, provide a plate-like surface that a sharp object, such as a scalpel or blade, may advantageously utilize to cut and reduce the target tissue against the cutting plate-like surface for removal and removal without risk of cutting the containment pouch, adjacent tissue, or retractor.

99-103, a shield 700 is shown for use in combination with a retractor 724. The retractor 724 is the same retractor 62 as described with reference to FIGS. 18 and 19. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible side wall 730. The side wall 730 defines a central opening extending along the longitudinal axis of the retractor 724. The second ring 728 can be compressed and inserted through the vaginal canal, where it expands to form a fixation means for the vagina. The first ring 726 is located outside the patient's body above the entrance to the vagina, where it can be rotated down on itself to retract and expand the vaginal canal.

In a hysterectomy, the uterus is detached from the body by instruments inserted through an abdominal port. After the uterus is detached, the shield 700 can be inserted directly into the vaginal canal. In such a configuration, the shield 700 curls itself into a contracted configuration, thereby aiding in the insertion of the shield 700, and when in place, the shield 700 expands to its normal relaxed configuration while positioned within the vaginal canal, thereby expanding and retracting the vaginal opening. The proximal flange 716 is located near the entrance to the vagina. The detached uterus can be grasped and drawn into the central lumen 714 of the shield 700, and then morselized by a blade against the shield, thereby reducing the size of the uterus or cutting it into several pieces, which can then be removed entirely through the vaginal canal.

In another embodiment, the containment bag is placed into the abdominal cavity through either the abdominal port or the vaginal canal. The retrieved uterus is placed into the containment bag. The tether of the containment bag is pulled through the vaginal canal. The ring of the containment bag is compressed into a low profile configuration, which facilitates pulling the proximal end of the containment bag through the vaginal canal. The ring of the containment bag is pulled outwardly and allowed to expand to an open configuration, thereby opening the mouth of the containment bag. The ring of the containment bag is positioned outside the entrance of the vagina. The ring of the containment bag can be rotated down on itself so that the side walls of the bag wrap around the ring of the containment bag. This action brings the retrieved uterus in the bag near the vaginal opening. The shield 700 is then inserted into the mouth of the containment bag and into the vaginal canal. The shield 700 curls downward into a compact configuration, which aids in insertion. The proximal flange 716 is positioned at or near the entrance of the vagina. In one embodiment, the proximal flange 716 of the shield 700 is snapped under the ring of the containment bag. The removed uterus can be grasped with a grasper and pulled into the central lumen 714 of the shield 700, where dissection can begin.

The distal end of the shield 700 is funnel-shaped with a radial dimension that gradually increases from the inflection point 722 toward the distal end 708 of the shield 700. This funnel-like shape advantageously aids in moving the avulsed uterus into the shield 700. The uterus is morcellated with the blade while it is at least partially located within the shield 700, and is then completely removed, either whole or in portions. The shield 700 advantageously protects the surrounding vaginal canal as well as the containment pouch from the sharp blade, thereby aiding in maintaining the integrity of the containment pouch and closed morcellation system.

In another embodiment, the same procedure is performed as described in the previous paragraph, but after the uterus is placed in the bag and the ring of the bag is pulled outside the body, the retractor 724 is inserted into the mouth of the bag. The second ring 728 of the retractor 724 is compressed for easy insertion into the mouth of the bag, and then the second ring expands to an open configuration within the bag at a location distal to the vaginal canal in the abdominal cavity. The first ring 726 of the retractor 724 located outside the body is rotated on itself so that the side wall 720 of the retractor 724 wraps around the first ring 726. This action not only retracts the vaginal canal but also retracts the bag out of the way, thereby moving the vaginal canal out of the way so that the shield 700 can be inserted. The bag is captured between the retractor and the vaginal canal to hold the bag in place and prevent it from entering or leaving the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724 located within the bag. The shield 700 may be curled downwards, if necessary, into a compact configuration, which then expands to self-anchor the shield 700 in place. The shield 700 is then coupled to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726 as shown in FIGS. 99-103. The uterus may then be grasped with surgical instruments and pulled out of the pouch of the containment bag and into the central lumen 714 of the shield 700, where it is morcellated with a blade while at least partially located within the shield 700, and then completely removed, either whole or in pieces. The shield 700 advantageously protects the surrounding vaginal canal as well as the containment bag from the sharp blade, thereby providing the surgeon with a mechanism to perform morcellation safely and quickly, while helping to maintain the integrity of the containment bag and the closed morcellation system.

In another variation, the same procedure is performed in the same manner as described in the paragraph above, except that the retractor 724 is placed in the vaginal canal and then the containment bag with the specimen therein is pulled through the vaginal canal. In this configuration, the removed uterus is placed in a containment bag placed in the abdominal cavity, and a tether attached to the proximal end of the containment bag is pulled by a grasper through the central lumen of the retractor, bringing the ring and mouth of the containment bag outside the patient's body. The ring of the containment bag can then be lowered while rotating on itself to bring the detached uterus closer to the opening. The flexible retractor 724 is then curled on itself into a compact configuration, and then the shield 700 is released, thereby reducing the size of the shield 700 laterally, which causes the shield to expand due to its bias, which causes the shield to expand laterally from the compact configuration. As the shield 700 expands, it self-anchores and retracts the containment bag, thereby creating a working channel in the central lumen 714 of the shield 700 for removal and morcellation of the dissected uterus. The proximal flange 716 of the shield 700 can be snapped under the ring of the containment bag or the first ring 726 of the retractor 724. The containment bag is captured between the retractor 724 and the shield 700 to prevent the containment bag from sliding proximally or distally during the procedure. The flange 716 can serve as an upper surface of a cutting plate against which a sharp blade can be cut for central removal. For all of the above hysterectomy procedures, the containment bag and retractor combination of FIG. 20 can be used in place of one or more of the containment bag and retractor 724.

In yet another embodiment, the shield 700 is used with a retractor 724 as shown in FIGS. 99-103. In such an embodiment, the retractor 724 is placed in the vaginal canal. The uterus is ablated using standard techniques either before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed to allow easy insertion into the vaginal canal, and then the second ring is expanded into an open configuration within the abdominal cavity at a location distal to the vaginal canal. The first ring 726 of the retractor 724, located outside the body, is rotated on itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action retracts the vaginal canal. The shield 700 is then inserted into the central lumen of the retractor 724. The shield 700 can be curled downward, if necessary, into a compact configuration, and then the shield 700 can expand to self-anchor the shield 700 in place. The shield 700 is then coupled to the first ring 726 of the retractor 724 by snapping the proximal flange 716 of the shield 700 under the first ring 726 as shown in FIGS. 99-103. The uterus can then be grasped with a surgical instrument and drawn into the central lumen 714 of the shield 700 where it is morcellated with a blade while at least partially located within the shield 700, and then completely removed, either whole or in pieces. The shield 700 advantageously protects the surrounding vaginal canal as well as the retractor 724 from the sharp blade, while providing the surgeon with a mechanism for safe and rapid morcellation.

104-107, another form of shield 800 adapted for use within the vaginal canal is shown. The shield 800 has a top end 802 and a bottom end 804 connected together by a sidewall 806. An opening 808 is formed in the shield 800 extending through the top end 802 and the bottom end 804. The shield 800 further includes a first flange 810 and a second flange 812. The first flange 810 extends in a distal direction from the bottom end 804. The first flange 810 is curved to form an elongated surface that is concave toward the longitudinal axis 816. The first flange 810 may also be a substantially flat elongated surface. The first flange 810 has a distal end 814 that is angled away from the longitudinal axis 816. The second flange 812 extends in a distal direction from the bottom end 804. The second flange 812 has a hook 818 configured to be attached to a ring of a containment bag or a proximal ring of a retractor by snapping under the ring. FIGS. 106 and 107 show the shield 800 coupled to a retractor 724. The retractor 724 is the same retractor described above with reference to FIGS. 18 and 19 and 99-103. The retractor 724 has a first ring 726 and a second ring 728 connected to each other by a flexible side wall 730. The side wall 730 defines a central opening extending along the longitudinal axis of the retractor 724. The second ring 728 can be compressed and inserted through the vaginal canal where it expands to provide a fixation means for the vaginal canal. The first ring 726 is located above the entrance to the vagina outside the patient's body where it can be rotated down on itself to retract and expand the vaginal canal.

The shield 800 will now be described in use during a surgical procedure, such as a hysterectomy, although the invention is not limited to use in hysterectomies and may be utilized in any targeted tissue removal or morcellation procedure. In a hysterectomy, the uterus is separated from the body by instruments inserted through an abdominal port.

In one configuration, the shield 800 is used with the retractor 724 shown in Figs. 106 and 107. In such a configuration, the retractor 724 is placed in the vaginal canal. The uterus is ablated using standard techniques either before or after the retractor 724 is placed in place. The second ring 728 of the retractor 724 is compressed to allow easy insertion into the vaginal canal, and then the second ring expands to an open configuration within the abdominal cavity at a location distal to the vaginal canal. The first ring 726 of the retractor 724 is located outside the body and is rotated on itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action retracts the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 and coupled to the retractor 724. The shield 800 is connected to the first ring 726 of the retractor 724 by snapping the second flange 812 of the shield 800 under the first ring 726 from the inside of the first ring 726 as shown in Figures 106 and 107. Additional hooks may be provided that connect the shield 800 to the retractor 724. The shield 800 covers or slips over the first ring 726 of the retractor 724 and one or more hooks 818 hook under the first ring 726 to secure the shield 800 to the retractor 724. The uterus may then be grasped with a surgical instrument, pulled in a proximal direction, and placed over or juxtaposed against the first flange 810. The first flange 810 of the shield 800 is curved, which advantageously supports and cradles the dissected uterus, preventing it from slipping off the first flange 810, while reducing the size of the uterus so that the surgeon can use the blade to cut and remove it through the vaginal canal. The first flange 810 advantageously serves as a cutting plate upper surface, allowing the blade to safely cut tissue near or in contact with the first flange 810 against the cutting plate upper surface. The angled distal end 814 of the first flange 810 provides an additional vaginal dilator and a ramp or ramp for moving and guiding the uterus proximally into the vaginal canal and toward the vaginal opening. At the proximal end of the shield 800, a ring-shaped portion of the shield 800 advantageously safely retracts the lips out of the way of the morcellating blade. While the uterus is at least partially located within the shield 800, it is morcellated with the blade and then completely removed, either whole or in sections. The shield 800 advantageously protects the surrounding vaginal canal, lips, and retractor 724 from the sharp blade, while providing the surgeon with a mechanism to perform the morcellation safely and quickly.

In another embodiment, the containment bag is placed into the abdominal cavity through either the abdominal port or the vaginal canal. The retrieved uterus is placed into the containment bag. The tether of the containment bag is pulled through the vaginal canal. The ring of the containment bag is compressed into a low profile configuration, which facilitates pulling the proximal end of the containment bag through the vaginal canal. The ring of the containment bag is pulled outwardly and allowed to expand to an open configuration, which opens the mouth of the containment bag. The ring of the containment bag is positioned outside the entrance of the vagina. The ring of the containment bag can be rotated down on itself to wrap the side walls of the bag around the ring of the containment bag. This action brings the retrieved uterus in the bag near the vaginal opening. The shield 800 is inserted into the mouth of the containment bag and into the vaginal canal and connected to the ring of the containment bag by hooking the second flange 812 onto the ring to secure the shield 800 to the containment bag. The retrieved uterus in the containment bag is grasped with a grasper and pulled over the first flange 810 of the shield 800. The beveled distal end 814 of the first flange 810 helps guide the uterus in the tilted position and supports it to be held for morcellation. With the uterus at least partially positioned adjacent the first flange 810, the uterus is morcellated with the blade and then completely removed, either whole or in portions. The shield 800 advantageously protects the surrounding vaginal canal as well as the containment pouch from the sharp blade, thereby helping to maintain the integrity of the containment pouch and closed morcellation system.

In another embodiment, the same procedure is performed as described in the paragraph above, but after the uterus is placed in the containment bag and the ring of the containment bag is pulled out of the body, the retractor 724 is inserted into the mouth of the containment bag. The second ring 728 of the retractor 724 is compressed to allow easy insertion into the mouth of the containment bag, and then the second ring expands into an open configuration within the containment bag at a location distal to the vaginal canal in the abdominal cavity. The first ring 726 of the retractor 724 is rotated on itself to wrap the side wall 720 of the retractor 724 around the first ring 726. This action not only retracts the vaginal canal but also retracts the containment bag out of the way, thereby clearing the vaginal canal so that the shield 800 can be inserted. This traps the containment bag between the retractor 724 and the vaginal canal, keeping it in place and preventing it from entering or leaving the vaginal canal. The shield 800 is then inserted into the central lumen of the retractor 724 located within the containment bag. The shield 800 is coupled to the first ring 726 of the retractor 724 by snapping the proximal flange 812 of the shield 800 under the first ring 726 of the retractor 724. The uterus is then grasped with surgical instruments and pulled out of the pouch of the containment bag into juxtaposition with the first flange 810 of the shield 800, whereupon the uterus is morcellated with the blade while in at least partial contact with the first flange 810, and then completely removed, whole or in pieces. The shield 800 advantageously protects the surrounding vaginal canal as well as the containment bag and retractor 724 from the sharp blade, thereby helping to maintain the integrity of the containment bag and closed morcellation system, while providing the surgeon with a mechanism to perform morcellation safely and quickly. For all of the above-described hysterectomy procedures, the containment bag and retractor combination of FIG. 20 can be used in place of one or more of the containment bag and retractor 724. It will also be appreciated that the present invention is not limited to hysterectomy procedures, but can be used to morsel, separate, and remove any tissue or organ.

108 and 109, a modified shield 900 is shown having a funnel 902 with retraction fingers 904 at its distal end. The funnel 902 defines a central opening 906. The proximal end of the shield 900 forms a proximal flange surface that constitutes a funnel-shaped entrance to the central opening and circumferentially surrounds the central opening 906. The shield 900 is inserted into a body orifice or wound incision by first inserting the retraction fingers 904 and then inserting or tilting the central portion of the funnel 902 into the opening. The proximal end of the funnel 902 rests on top of the abdominal or other external surface of the body. The proximal flange provides a cutting plate location where tissue can be morcellated. The retraction fingers 904 help retract the incision or body orifice and help keep the shield 900 anchored in place. The retraction fingers 904 form a distal flange that extends only partially around the circumference of the distal end of the central opening 906. The retraction fingers 904 are curved such that the side profile of the shield 900 where the retraction fingers 904 are located is substantially C-shaped, with the top of the letter "C" extending a greater distance laterally than the bottom of the "C". The funnel 902 also provides protection to the surrounding tissue as well as the containment bag and retractor when used in conjunction with the shield 900. For example, the containment bag is inserted through a body opening or incision and the mouth of the containment bag is pulled back from the incision after the specimen is inserted into the bag. The proximal end of the containment bag is placed on the abdomen and the shield 900 is inserted into the mouth of the containment bag and secured by the retraction fingers 904. A grasper is inserted into the central opening 906 and the specimen in the containment bag is pulled toward the central opening 906. The blade is then used to divide the specimen so that it can be removed whole or in pieces through a small incision/orifice. The shield 900 is made of a firm, rigid plastic that is thick enough to prevent and reduce the possibility of penetration by the blade, while still protecting adjacent tissue and maintaining the integrity of the containment bag.

In another embodiment, the shield 900 is used with the same retractor as described above. The retractor is placed in the incision either before or after the bag is placed, and then the shield 900 is inserted into the mouth of the containment bag and the retractor. In one embodiment, the proximal end of the shield 900 is sized and shaped to fit over or snap onto the proximal ring of the containment bag or retractor. One embodiment of the shield 900 that fits over the proximal ring of the retractor or containment bag is shown in FIGS. 109B and 109C with an oval central lumen 906 and a circular central lumen 906, respectively. The shield 900 in FIGS. 109B and 109C has at least one hook 905 that is configured to be attached to the ring of the retractor or containment bag.

109 in particular, the funnel 902 has a circumferential rim 908 raised from the inner surface. The rim 908 is configured to couple to a blade, which will be described in more detail below. The funnel 902 also has a raised portion 910. The raised portion 910 is configured to hold a second shield 912. The second shield 912 is shown in FIG. 110. The second shield 912 is generally similar to the shields described with reference to FIGS. 71-86 and other shields described herein. In one form, the second shield 912 is spiral in shape and is vertically collapsible and expandable as described above. In the form shown in FIG. 110, the second shield 912 is not spiral, but is substantially cylindrical with a concave outer surface and gaps 914 to form a C-shaped shield. The second shield 912 has a proximal flange 916 and a distal flange 918 connected together by a central portion 920. The proximal flange 916 may have a tab or finger pull to aid in its removal from the body opening/incision. The second shield 912 has a contracted configuration with a smaller lateral dimension than the normal relaxed configuration shown in FIG. 110. The contracted configuration is optimal for insertion into a wound or body opening and for connecting the second shield 912 to the first shield 900. The second shield 912 is made of a soft plastic with sufficient properties to prevent penetration by a blade or other sharp object or instrument under normal use to protect adjacent tissue.

111, there is shown a first shield 900 coupled to a second shield 912. The C-shaped second shield 912 is positioned within the first shield 900 such that a proximal flange 916 of the second shield 912 rests on at least a portion of the inner surface of the funnel 902 of the first shield 900. The raised portion 910 of the shield 900 is received within a gap 914 of the second shield 912. The coupling with the raised portion 910 prevents the second shield 912 from moving around within the funnel 902. The first shield 900 provides protection along a portion of the lower circumference where the retraction fingers 904 are located, and the second shield 912 completes the circumferential protection at the distal end. The second shield 912 provides 360° circumferential protection at the proximal end that is positioned within the incision/body opening. The distal flange 918 also provides a funnel-shaped entrance into the central lumen 922 of the second shield 912, which aids in moving tissue into and out of the body while providing protection of the surrounding tissue, containment bag, and retractor, if used. The shields 900, 912 may be used with a manual bladed morcellator or with a short motorized morcellator similar to those described above with reference to Figures 87-90.

112 and 113, a blade carrier 926 is shown coupled to a first shield 900, which is coupled to a second shield 912 to form another form of shield system. The blade carrier 926 has a funnel 928 defining a central opening 930, a blade receiver 932, and a blade 934. The funnel 928 has a funnel-like shape and has a circumferential hook configured to fit over, snap onto, and couple to the first shield 900. Specifically, as shown in FIG. 113, the circumferential hook of the funnel 928 mates directly with the raised circumferential rim 908. In one form, the blade carrier 926 is snap-fitted to the first shield 900 such that it is held vertically but rotates relative to the first shield 900. The blade receiver 932 receives the blade 934 in a blade channel 936. The blade 934 is connected to a blade handle 938 by a pin 940, which connects the blade 934 to an inner rod 942. Details of the blade housing 932 are also shown in Figs. 114 and 115. In one form, the inner rod 942 to which the blade 934 is pinned by the pin 940 reciprocates relative to the blade handle 938. The reciprocating motion can be provided manually by moving the inner rod 942 back and forth at its proximal end relative to the blade handle 938 to effect back and forth movement of the blade 934 at its distal end. The reciprocating motion can also be provided by an electric motor (not shown) located in the blade handle 938 at its proximal end in a removable and reusable handle attachment. The blade receiver 932 can be provided in two parts, a first part and a second part. The first portion has a blade channel 936 with a slot 944 configured to receive a pin 940 and guide the translation of the blade 934 within the blade channel 936. One end of the pin 940 is coupled to the blade 934 and the other end of the pin 940 is coupled to a distal end of an inner rod 942 that is housed within a second portion of the blade receiver 932, which together house the blade 934. The blade receiver 932 is coupled to a funnel 928 of the blade carrier 926. The inner rod 942 is moved distally to expose the blade 934 for cutting tissue when in the exposed position. With the blade 934 in the exposed state, the blade carrier 926 can be rotated relative to the first shield 900, which can cut tissue circumferentially along at least a portion of the interior of the central lumen. The blade 934 can be retracted to a retracted position in which it is at least partially hidden within the blade receiver 932. When in the retracted position, the sharp sides of the blade 934 are substantially hidden, thereby making the blade carrier 926 safe to handle. The blade 934 can be moved manually or automatically from the retracted position to the exposed position to cut tissue. This reciprocating cutting action can be selectively performed manually by a user or automatically if tissue cutting is desired or performed reciprocating in a continuous manner. Also, the reciprocating cutting action can be performed simultaneously with rotation of the blade carrier 926 relative to the first shield 900 or can be performed intermittently with rotation of the blade carrier 926. By moving the blade 934 from the retracted position to the exposed position, the blade 934 moves into a plane that includes the distal end of the central opening 930, at an angle to this plane, or substantially perpendicular to this plane. This plane may also be defined as a plane perpendicular to the longitudinal axis of the instrument or the longitudinal axis of the central lumen. The amount of exposure of the blade 934 may be user selectable, allowing selective cutting. For example, the blade 934 may be partially exposed from a fully retracted position, in which case the blade 934 cannot cross a plane that includes the distal end of the central opening 930. The blade 934 may be configured to extend beyond the distal end of the central opening 930 of the blade carrier 926, but not beyond the distal end of the second shield 912, such that the blade 934 and the blade path are always surrounded and enclosed by either one or more of the first shield 900, the second shield 912, and the blade carrier 926. In another embodiment, the distal end of the blade 934 may extend slightly beyond the distal end of the second shield 912.

In one form, the blade 934 is fixed relative to the blade receiver 932 and the blade does not reciprocate relative to the blade carrier 926, but only rotates relative to the first shield 900. In another form, the blade carrier 926 is fixed relative to the first shield 900 in the sense that it does not rotate relative to the first shield 900, but the blade carrier is configured so that the blade 934 reciprocates relative to the blade carrier 926. The rotary cutting action has the purpose of increasing the chances of removing the specimen as a single excision rather than multiple pieces while ensuring protection to the surrounding tissue. Also, the blade 934 is shown to curve downward into the central opening. In another form, the blade 934 extends radially inward in a plane perpendicular to the central lumen, and the blade has a configuration similar to a guillotine or cigar cutter. It is within the scope of the present invention for the blades 934 to have an approach angle of 0° to less than 180°, where an approach angle of zero means that the blades 934 intersect a plane perpendicular to the central lumen longitudinal axis that is parallel to the longitudinal axis at the 12 o'clock position. An approach angle of less than 180° means that the blades 934 intersect a plane perpendicular to the longitudinal axis when viewed from below that plane at approximately the 5 o'clock and 7 o'clock positions.

FIG. 116 shows the blade 934 of the blade carrier 926. The blade 934 has a sharp tip and sharp sides configured to penetrate and cut tissue.

117-119, a shield assembly 950 is shown including a blade carrier 926, a first shield 900, and a second shield 912. A blade 934 is shown coupled to a blade handle 938 having a motor housed in a removable handle extension 946. The first shield 900 has a notch 948 visible in FIGS. 109, 111, 117, and 118. The notch 948 facilitates separation and removal of the blade carrier 926 from the first shield 900 by providing a location for a finger to snap the blade carrier 926 off the first shield 900.

120-126, another form of shield assembly is shown. The shield assembly includes a first shield 900, a second shield 912, and a blade carrier 926. The blade carrier 926 has a blade receiver in two parts 932a, 932b, a blade 934, an inner rod 942, a pin 940, and a blade handle 938. The length of the blade handle 938 is not shown to scale and is depicted for illustrative purposes to include a variation in which a reusable handle extension 946 can be attached to the proximal end of the blade handle 938 in an embodiment in which the shield assembly is disposable. The variation of Figs. 120-126 is substantially the same as the form shown in Figs. 109-119 with some modifications. The second shield 912 is not a cutting tube, but rather is of the spiral nature described above. The second shield 912 is shown in Fig. 120 in a compressed pair. The first shield 900 has an outer rim 908 disposed about the top periphery of the first shield 900. The funnel 928 of the blade carrier 926 snaps under the outer rim 908 in the configuration shown in FIGS. 120-126.

In another form of shield, the shield is formed around a helical surface whose cross section perpendicular to the helical guideway is a parabola. Once removed, the helical surface compresses itself into the shape of a catenary within which the shield lies during its rest state. The following parametric equations cover the shield variations:

x(u,v)=β[cos(α)sinh(v)sin(u)+sin(α)cosh(v)cos(u)](1)

y(u,v)=γ[-cos(α)sinh(v)cos(u)+sin(α)cosh(v)sin(u)](2)

z(u,v)=δ[ucos(α)+vsin(α)](3)

The value α is a constant fixed parameter that changes the progression during the transformation of the helical surface into a catenary surface. For α=0, a helical surface is generated, and for α=π/2, a catenary surface is generated. The shield variant is a value of α greater than 0 and less than π/2, which is considered to be on the open interval of (0,π/2). Another variant of the shield has a value of α greater than 0 and less than or equal to π/2, which is considered to be on the open interval of (0,π/2). Another variant of the shield has a value of α greater than or equal to 0 and less than or equal to π/2, which is considered to be on the open interval of (0,π/2). The parameters β,γ,δ are also constants. For β,γ,δ∈R\{0}, if β<0,γ<0,δ<0, the rotation flows counterclockwise. For any β,γ,δ>0, the rotation flows clockwise. The parametric equations create a surface on the u-v plane. The values of vectors u and v can be considered when u∈(-π, +π) and v∈(-∞, +∞).

127, another embodiment of the containment bag 1000 of the present invention is shown. The bag 1000 has a sidewall 1002 that defines an opening 1004 at a proximal end. The bag 1000 has a longitudinal axis that is substantially perpendicular to the opening 1004. The sidewall 1002 can form any shape for the bag 1000, such as a cylindrical, elongated, spherical, etc., and the sidewall may or may not have a base or bottom panel as a base from which the sidewall 1002 extends toward the proximal end. The sidewall 1002 can extend downward to form a seamed or seamless base. For example, the bag 1000 may be formed by a flat length of material that is folded and joined along its sides, so that a seam is not formed along the base, but instead is located at the side of the bag 1000 and extends upwardly substantially perpendicular to the longitudinal axis.

Still referring to FIG. 127, the containment bag 1000 has at least a first ring 1006 disposed at or near the opening 1004 of the bag 1000. The first ring 1006 is connected to the bag 1000. A second ring 1008 is shown in FIG. 127. The second ring 1008 is disposed a distance below the first ring 1006 and connected to the bag 1000. The first ring 1006 and the second ring 1008 are elastic and compressible from an expanded configuration that is circular or oval in shape to a collapsed elongated configuration having reduced lateral dimensions suitable for entering a small incision, a body opening, or through the lumen of a trocar. In one variation, the second ring 1008 is not used. The bag 1000 can be collapsed to a short length along the longitudinal axis of the bag 1000. Next, if a second ring 1008 is used, the first ring 1006 and the second ring 1008 are easily compressed in the lateral dimension by squashing them into their collapsed elongated configuration to subsequently deploy the containment bag 1000 within the abdominal cavity. Once within the abdominal cavity, the compressed rings 1006, 1008 will return to their original expanded open configuration. With the rings 1006, 1008 in their expanded configuration within the abdominal cavity, the bag 1000 is easily oriented within the abdominal cavity. Locations within the perimeter of the rings 1006, 1008 are targets for placement of the excised tissue or organ. In one variation, the bag 1000 in the collapsed configuration is not face up, as either side can be used to place the specimen within the interface of the first/second rings 1006, 1008. The first ring 1006 serves as a circumferential guide for placement of the specimen within the perimeter of the first ring 1006, and therefore may be brightly colored or colored in contrast to the remainder of the pouch 1000 or its intended enclosure, so that the first ring can be easily viewed laparoscopically. After the resected tissue or organ is placed within the perimeter of the first ring 1006, the first ring 1006 is moved toward the exit incision or body orifice. Lifting the ring 1006 results in the tissue being resected falling or deeper into the interior space 1010 of the pouch. Moving the pouch toward the exit opening results in the tissue specimen becoming lodged within the interior space 1010 of the pouch 1000. The first ring 1006 is compressed into a reduced elongated form and pulled through the exit body orifice, opening, or exit incision. Once through the opening, the first ring 1006 self-expands and springs back into an open, enlarged configuration that sits outside the patient's body above or near the abdominal wall and covers the exit orifice, opening or exit incision. The first ring 1006 is turned or flipped over on itself by inverting it outwards or inwards to wrap the bag 1000 around the first ring 1006. The bag 1000 can be unfolded from the first ring 1006 by turning the first ring 1006 over on itself in the opposite direction. In one variation, the first ring 1006 has a cross-section whose length is greater than its width. The elongated cross-section of the first ring 1006 advantageously keeps the side walls 1002 of the bag wrapped around the first ring 1006. If the cross section of the first ring 1006 is circular, the first ring 1006 can easily rotate on and off itself, thereby rolling the side wall 1002 on or off relative to the first ring 1006. By rolling the first ring 1006 on itself, the bag 1000 is pulled upwards, bringing the specimen within the bag 1000 closer to the opening. Rolling the first ring 1006 on itself reduces the distance of the side wall 1002 between the first ring 1006 and the second ring 1008, thereby forcing the second ring 1008 closer to the first ring 1006, so that the abdominal wall is secured between the first ring 1006 and the second ring 1008, thereby securing the bag 1000 to the patient for morcellation. The rolling action of the bag 1000 reduces the volume of the bag 1000 to form a well-formed and taut protective apron at the opening as well as outside the patient's body surrounding the opening. The rolling action can also serve to retract the tissue at the opening, thereby advantageously enlarging the opening for easy tissue removal from inside the bag 1000. The specimen is then extracted from the bag 1000 by morcellating the specimen manually with a blade or automatically with an electronic morcellator to a size and shape that allows it to pass through the opening and be removed from the bag 1000. After the tissue specimen is removed from the bag 1000, the first ring 1006 is rotated back on itself, widening the space between the two rings 1006, 1008 if necessary. Thus, the second ring 1008 is compressed to its reduced elongated form and pulled outside the patient's body through the opening, and the bag 1000 is removed from the patient.

The bag 1000 and/or the sidewalls 1002 of the bag 1000 are made of a material that is extremely cut-resistant to sharp objects, such as scalpel blades and blades used in electronic morcellators. In one form, the bag 1000 is made of an extremely cut-resistant woven fabric, such as DYNEEMA® fibers. The cut-resistant material is ultra-high molecular weight polyethylene (UHMWPE), also known as high modulus polyethylene or high performance polyethylene. In one form, the bag 1000 is made of DYNEEMA® coated with an elastomer to prevent fluid from crossing the plane of the material. In one form, the entire bag 1000 is made of the cut-resistant material. In another form, only selected portions of the bag 1000 are made of the cut-resistant material. In one embodiment, at least a portion of the side wall 1002 of the bag 1000 located between the first ring 1006 and the second ring 1008 is made of a cut-resistant material. In another embodiment, only a portion of the bag 1000 is made of a cut-resistant material in the area where a cut is expected. In another embodiment, the lower portion of the distance between the two rings 1006, 1008 is made of a cut-resistant material, and the upper portion of the distance between the two rings 1006, 1008 is used for wrapping around the first ring 1006. In another embodiment, the upper portion of the distance between the two rings 1006, 1008 is made of the same cut-resistant material, but with a thickness or fiber thickness that is smaller than the thickness of the side wall or the fiber thickness of the lower portion. In an embodiment where only a portion of the bag 1000 is made of a cut-resistant material, the remaining portion is made of a suitable polymer material as described above. In one form, using a bag 1000 made of a cut-resistant material eliminates the need for the retractor described above to be used in conjunction with the bag 1000 during the morcellation procedure. Thus, the bag 1000 advantageously provides cut resistance and safety shielding during morcellation as well as helps to retract the opening through which it is inserted. Because the bag 1000 is cut-resistant, the bag 1000 can be used without a shield/guard of the type described above. The lack of a shield or guard advantageously provides a larger working space.

The bag 1000 embodiment is comprised of one or more sheets, membranes, fibers, and/or strands of material that provide the sheath with cut resistance as well as abrasion and puncture resistance. Suitable sheets, membranes, fibers, and/or strands are comprised of at least one of natural polymers, semi-synthetic polymers, synthetic polymers, metals, ceramics, glass, carbon fibers, carbon nanotubes, and the like. Suitable natural fibers include cellulose, silk, and the like. Semi-synthetic fibers include nitrocellulose, cellulose acetate, rayon, and the like. Suitable synthetic fibers include polyesters, aromatic polyesters, polyamides (NYLON®, DACRON®), aramids (KEVLAR®), polyimides, polyolefins, polyethylenes (SPECTRA®), polyurethanes, polyureas, polyvinyl chloride (PVC), polyvinylidene chloride, polyetheramides (PEBAX®), polyetherurethanes (PELLETHANE®), polyacrylates, polyacrylonitrile, acrylics, polyphenylene sulfide (PPS), polylactic acid (PLA), poly(diimidazopyridinylene-dihydroxyphenylene) (M-5), poly(p-phenylene-2,6-benzobisoxazole) (ZYLON®), liquid crystal polymer fibers (VECTRAN®), and the like, as well as blends, copolymers, composites, and mixtures thereof. Suitable metals include stainless steel, spring steel, nitinol, superelastic materials, amorphous metal alloys, and the like. The bag 1000 has a retractor assembly that provides both specimen containment and tissue retraction features. Additional retraction features and materials and configurations that may be incorporated into the bag 1000 in accordance with aspects of the present invention are described in U.S. Patent Application Publication No. 2011/00542610 A1, which is incorporated by reference in its entirety and is hereby incorporated by reference in its entirety.

Currently available morcellators generally cut tissue with an exposed and unprotected instrument, such as a sharp blade or energy tip, within the body cavity. With most morcellators, this creates additional risks as the exposed blade/tip can easily contact unintended areas, thereby causing damage to organs, tissues, blood vessels, etc. Because current morcellators cut tissue in open areas, small pieces of cut tissue can be left behind after the tissue removal procedure. These pieces can cause endometriosis in women, where uterine cells attach themselves to other organs or tissue walls. These pieces can also contain cancer cells that must be removed in their entirety. Currently, if the tissue is suspected to be cancerous, the entire mass is removed open rather than laparoscopically, which increases the risk of infection for the patient and increases recovery time. Even if all of the pieces are found, the surgery time still increases due to the extra step of examining the body cavity for small elements of tissue. Additionally, current morcellators require two people to perform the procedure. One must pull the tissue through the tenacious morcellator while the other must hold the remaining tissue mass from inside the body cavity close to the tip of the rotating blade. As this procedure is being performed, the specimen is typically dropped or torn away from the instruments that hold it in place during morcellation. This creates additional time as the person responsible for positioning the specimen in front of the morcellator must find the tissue, re-clamp the instruments to it, and then place the specimen in front of the morcellator again. Thus, while morcellation within a containment means, such as a bag, is desirable, the bag itself presents a potential for puncture and spillage of contents. The specimen bag in one form of the present invention has a protective inner layer of material that resists puncture caused by the tenacious jaws and the rotating morcellator blade. Also, because the morcellator is locked in a stationary position by use of any of the stabilizers described above, the risk of the blade contacting the bag is greatly reduced. With a specimen bag, the entire tissue sample is contained, so if small pieces fall out of the larger specimen during morcellation, they will be removed when the bag is pulled from the patient. This increases patient safety and reduces the operative time for the morcellation procedure, since there is no need to search for tissue pieces left behind. The specimen bag supports the tissue and keeps it in place. This allows one person to perform the morcellation procedure instead of two. It also reduces the time required to continually reposition and reclamp the specimen.

128-134, the tissue morcellator 3000 is a multi-component medical instrument used to capture tissue specimens, such as uterus, within the human body under laparoscopic surgical conditions and reduce the size of such tissue specimens for removal through a small incision, body orifice, orifice, which may or may not include a laparoscopic port. The morcellator 3000 has a gear housing 3016 that houses a gear train, as can be clearly seen in FIG. 133, which is connected to a flexible transmission shaft 3018 that is connected at its proximal end to a motor for rotating the morcellator blade 3010. The morcellator 3000 has a central working channel lumen 3020 that extends through the length of the morcellator 3000. The inner and outer tubes of the morcellator 3000 are stationary and do not rotate relative to the moving blade 3010 so as not to present a moving surface to the tissue as it is being removed through the lumen 3020. In one form, the morcellator 3000 has a camera 3022. The camera 3022 may be integral with the remainder of the morcellator 3000 or may have a separate add-on that slides along the morcellator shaft and is coupled to the morcellator 3000 as shown in FIG. 134. Also, as shown in FIG. 132, the distal end of the morcellator shaft has a fixed protruding appendage that covers at least a portion of the blade that extends distally to interrupt the morcellation of the tissue to prevent the tissue from rotating relative to the instrument.

128-134, the morcellation system further includes a barb 3012 having an elongated shaft 3028 and a jaw-like grasper at a distal end controlled at a handle 3024 at a proximal end to open and close the jaws 3026 to grasp tissue. The shaft 3028 and jaws are configured to extend and protrude from the distal end of the morcellator shaft while fitting within the working channel 3020 of the morcellator 3000. The barb handle 3024 is designed to be held vertically in either the left or right hand, and the ergonomic design means that the hand and arm optimize the upward pulling motion. The handle 3024 has a lever 3030 that can be squeezed toward the handle 3024 to close the jaws 3026 as shown in FIG. 129. Alternatively, the lever 3030 can be squeezed to open the jaws 3026. The lever 3030 is under spring tension such that the lever 3030 springs open and away from the handle 3024, which can define a closed configuration of the jaws 3026, allowing the user to focus on pulling the tenaculum 3012 upward to remove tissue. Alternatively, the trigger is under spring tension such that the lever 3030 springs open and away from the handle 3024 to open the jaws 3026.

130-132, the tenacious jaws 3026 have a curved distal tip 3032. The jaws 3026 include upper and lower jaws hinged to one another. Each of the upper and lower jaws has a rounded and curved distal end that is free of any sharp points along the curve traced by the distal end 3032 as the jaws 3026 open and close. In the closed configuration shown in FIGS. 130 and 131, the curved distal tip 3032 has no exposed sharp points or edges that may pose a danger to the integrity of the tissue or pouch when in the open or closed configuration. The interior of the upper and lower jaws include teeth 3034. The distal tip 3032 also includes upper and lower jaw interlocking teeth 3034 that provide a smooth curved exterior surface to provide a positive hook to the grasped tissue while protecting any surrounding tissue and/or pouch. FIG. 132 shows the jaws 3026 in an open configuration, next showing the pathway 3036 during opening and closing of the tenaculum, and then showing the distal end 3032. The curved distal end 3032 advantageously protects the pouch being morcellated from puncture as the tissue is grasped. Even when the jaws 3026 are fully open, the curved distal end 3032 of the jaws can protect the pouch from unwanted puncture.

135A-135D and 136A-137B, a morcellation system includes a specimen collection container bag 3002. The morcellation system described may be adapted for use with a powered morcellator as described above, or may be used in a manual morcellation method. The bag 3002 is shown in a flattened state in FIG. 135A and in a rolled-up state in FIGS. 135B-135C. The bag 3002 has a bag ring 3004 surrounding an opening or mouth of the bag 3002. FIG. 136A shows a tissue sample 3006 captured within the bag 3002 with the bag ring 3004 pulled outward. FIG. 136B shows the bag ring 3004 pulled completely through the body opening to expose the interior of the bag 3002 to the outside of the body for removal of the sample 3006 within the bag 3002. In FIG. 136B, tissue guard 200 is shown ready for insertion into a body orifice. Although tissue guard 200 is shown, any tissue guard of the present invention may be employed.

137A-137C and 138A-138C, another form of bag 3002 is shown. Bag 3002 has a bag ring 3004 with an elongated cross section, such as that shown in FIG. 137C. Bag 3002 in FIGS. 137A-137C is configured to roll down the side walls of bag 3002 onto bag ring 3004. FIG. 138A shows bag 3002 with a tissue 3006 specimen located therein. Bag ring 3004 is pulled through a body opening to the body surface. FIG. 138B shows bag ring 3004 pulled all the way to the surface, and FIG. 138C shows bag ring 3004 turned or flipped over itself to reduce the length of the bag side walls and bring the bag contents to the surface where they can be easily morcellated, as indicated by the arrows in FIG. 138C and described herein above. The bladder ring 3004 is not limited to the ring having the cross section of FIG. 137C, and any cross section that allows the bladder to be wrapped around the bladder ring is within the scope of the present invention. The bladder ring 3004 is flexible so that it can be crushed and compressed into an elongated shape, so that the bladder ring can be inserted and removed through a small incision or body opening. The elastic bladder ring 3004 expands upon release to assume its open mouth configuration that allows easy placement of the specimen 3006 into the interior of the bladder 3002. The bladder 3002 has an open top, and the semi-rigid bladder ring 3004 is attached to the open top at or near the mouth of the bladder 3002. The bladder 3002 can be deployed in the body, for example in the abdomen, with a trocar or other deployment instrument. The bladder 3002 can be manipulated with a grasper. The specimen 3006 is placed into the bladder 3002 and the bladder 3002 is retrieved through a body wall 3056, for example the abdominal wall. The entire pouch 3002 will not pass through the small laparoscopic incision due to the large size of the specimen 3006. The semi-rigid pouch ring 3004 is the only part that reaches the surface with the remainder of the pouch remaining within the abdominal cavity of the body. The cross section of the semi-rigid ring allows for the pouch 3002 to be shortened by a rolling technique. This not only shortens the pouch 3002 but also aids in wound retraction. The tissue 3006 sample acts as an anchor allowing retraction of the wound opening, thereby allowing a motorized or manual morcellation instrument to achieve high approximation of the tissue 3006. Once the pouch 3002 is in place, morcellation can begin. As the tissue sample 3006 decreases in size, the semi-rigid pouch ring 3004 can be rotated further on itself to bring the tissue 3006 closer to the surface and allow easy access for morcellation. Once a sufficient amount of tissue 3006 has been removed, the pouch 3002 can then be removed from the patient. FIG. 138C shows the tissue guard 200 ready for insertion into a body opening and into the pouch 3002.

139A-139C, the bag 3002 is connected to a conveying shaft 3038 configured to open and close the mouth of the bag 3002. The conveying shaft 3038 is used to conveniently scoop the specimen 3006 when in the open-mouth configuration. The conveying shaft 3038 is operated to close the mouth of the bag 3002 after capturing the specimen 3006 and bringing the bag ring 3004 through the body opening to the surface for dissection and removal of the specimen 3006. The bag 3002 has an open top, at which a semi-rigid bag ring 3004 is attached. The bag 3002 is attached to a bifurcated (two fork) shaft 3038. The forks are made of a semi-rigid material, for example spring steel. The purpose of the conveying shaft 3038 is to allow the bag to be manipulated with great precision and great ease. The system is deployable in the abdomen via a trocar cannula 3044. The specimen 3006 is placed into the sack 3002, which is then retrieved through the abdominal wall 3056. To retrieve the sack 3002, the bifurcated shaft 3038 is pulled through the trocar cannula 3044 until a corner of the sack 3002 enters the distal tip of the trocar cannula 3044. Once the sack 3002 is engaged with the trocar cannula 3044, the sack 3002 can be pulled up through the wound opening to the surface. The entire sack 3002 does not pass through. The semi-rigid sack ring 3004 is the only portion that can reach the surface. Once at the surface, the bifurcated delivery shaft 3038 can be removed from the semi-rigid sack ring 3004. The cross section of the semi-rigid sack ring 3004 allows for the sack 3002 to be shortened by a rolling technique. This not only shortens the sack 3002, but also aids in wound retraction. The tissue 3006 sample acts as an anchor to allow retraction of the wound opening, thereby allowing a powered or manual morcellation instrument to achieve high approximation of the tissue 3006. Once the sack 3002 is in place, morcellation can begin. As the tissue 3006 sample is reduced in size, the semi-rigid sack ring 3004 can be rotated further on itself to bring the tissue 3006 closer to the surface and allow easier access for morcellation. Once a sufficient amount of tissue 3006 has been removed, the sack 3002 can then be removed from the patient. In another configuration, the sack 3002 includes a second sack ring 3040. The second sack ring 3040 is attached to the sack 3002 approximately mid-distance below the sack 3002. This second sack ring 3040 acts as an anchor to allow the sack 3002 to be shortened while simultaneously retracting the wound to its greatest potential opening. The sac 3002 is attached to a bifurcated (two-pronged) delivery shaft 3038. The forks are semi-rigid. The first sac ring 3004 is turned/flipped on itself while the first sac ring 3004 is outside the patient's body. The cross section of the semi-rigid first sac ring 3004 allows for the sac 3002 to be shortened by a rolling technique. This not only shortens the sac 3002 but also aids in wound retraction. The second sac ring 3040, located midway down the sac 3002, acts as an anchor allowing maximum retraction of the wound opening. This allows for greater access to the tissue 3006 by various morcellation instruments. Once the sac 3002 is in place, morcellation can begin. Once a sufficient portion of the tissue 3006 has been removed, the sac 3002 can be removed from the patient.

140A and 140B and 141A-141D, another form of the bladder 3002 of the present invention is shown. The bladder 3002 has a sidewall defining an interior and a mouth. A first bladder ring 3004 and a second bladder ring 3040 are provided. The second bladder ring 3040 is connected to one another by the sidewall while being spaced distally from the first bladder ring 3004. The bladder 3002 has a balloon 3042 provided at the bottom of the bladder 3002. The balloon 3042 forms at least a portion of the base of the bladder, and the balloon has a deflated state and an inflated state. The interior of the balloon 3042 is interconnected to an inflation pressure source that provides a positive pressure into the balloon 3042. The inflation pressure source can also provide a negative pressure to draw inflation fluid to deflate the balloon 3042 if desired by a user. The inflation pressure source is activated manually or automatically by the user. The balloon 3042 at the base of the bladder 3002 is spaced distally from the second bladder ring 3040 as shown in FIG. 140A. FIG. 141A shows the bladder 3002 inserted into the body through the body wall 3056 with the first bladder ring 3004 pulled to an exterior position to allow access to the interior of the bladder 3002 so that the specimen 3006 contained therein can be removed from the bladder 3002. FIG. 141B shows the proximal end and mouth of the bladder 3002 being pulled until the second bladder ring 3040 substantially engages the underside of the body wall 3056. FIG. 141C shows the first bladder ring 3004 being turned on itself to wrap the sidewall of the bladder 3002 around the first bladder ring 3004. As the first bladder ring 3004 is turned on itself, the length of the sidewall located between the first bladder ring 3004 and the second bladder ring 3040 is reduced. This reduction in the length of the sidewall brings the base of the bladder 3002 and the specimen contained therein closer to the surface opening of the body. FIG. 141D shows the balloon 3042 in an inflated state, which further lifts the specimen 3006 closer to the opening for easier visualization, morcellation and removal. The balloon 3042 advantageously provides an additional protective interface or barrier between the interior and exterior of the bladder 3002. For example, if a morcellation instrument, such as a scalpel, powered morcellator or grasper, accidentally creates a tear in the proximal end of the balloon 3042 facing the interior of the bladder 3002, the balloon 3042 may deflate, but the overall integrity of the bladder 3002 is not compromised. 3042 is inflated because the containment barrier against the exterior or sidewall of the bag remains intact. In essence, the balloon 3042 provides a double wall that provides additional protection at the base location where sharp instruments may possibly be struck during morcellation. The inflatable base of the bag 3002 also provides a pedestal effect for the tissue specimen 3006 even if the center of the tissue 3006 is not located on top of the balloon 3042. The inflatable base of the bag 3002 also provides a moat-like location for bodily fluids, e.g., blood, to drain from the specimen 3006 when inflated. When inflated, the inner wall of the balloon 3042 is significantly more spaced from the outer wall of the double walled structure of the base, thereby keeping the outer wall away from instruments and more likely to remain intact in the event of a breach in the inner wall. The double walled sidewall may be used throughout the bag 3002 and not just at the base location. The breach of the balloon 3042 and the resulting deflation provide a visual notification to the user that a sharp instrument has hit the balloon, alerting the user to ensure safety of the outer wall as they proceed with removal with extra care. This is in contrast to a single wall configuration, which means that the breach in the side wall is a breach in the exterior of the bag 3002 without warning. After the specimen 3006 is lifted to the surface, the morcellation can easily proceed as the specimen 3006 can be easily visualized from outside the body through the mouth of the bag 3002. The balloon 3042 can be any inflatable member, and such a balloon can be incorporated into the floor of the bag 3002. When morcellation is being performed, the size of the tissue is reduced. This can result in the specimen becoming lost within the bag 3002 and being difficult to find with the morcellator and instrument. Inflating the balloon 3042 lifts the tissue 3006 closer to the edge of the morcellator and instrument, making the tissue sample 3006 much easier to access.

142A-142C and 143A-143D, another form of containment bag 3002 with inflatable sidewalls is shown. The bag 3002 has sidewalls formed with an open top that serves as a mouth or entryway into the interior of the bag 3002. The bag 3002 has a first semi-rigid bag ring 3004 attached to the top near the opening. Also, a second bag ring 3040 is attached about a mid-distance below the bag 3002. The second bag ring 3040 serves as an anchor that can shorten the bag 3002 while simultaneously retracting the wound to its fullest potential opening. The bag 3002 has air channels 3008 to aid in the expansion of the lower portion of the bag 3002 containing the specimen. By expanding the lower portion, the visibility of the specimen from the top side is greatly increased. This also helps increase the speed at which morcellation can be performed. The sack 3002 is attached to a forked shaft 3028. The forks are semi-rigid. The purpose of the delivery shaft 3028 is to allow the sack 3002 to be manipulated with precision and with great ease. The system can be deployed through the body wall 3056 into the abdomen or into other parts of the body or into a body orifice. The tissue sample 3056 is placed into the sack 3002 and the sack 3002 is retrieved through the body abdominal wall 3056. To retrieve the sack 3002, the forked shaft 3028 is pulled through the trocar until a corner of the sack 3002 is in the trocar. Once the sack 3002 is engaged with the trocar, it can be pulled up to the surface as shown in FIG. 143A. Once at the surface, the forked shaft can be removed from the first semi-rigid sack ring 3004. The entire sack 3002 does not pass through. The semi-rigid first ring 3004 and a portion of the side wall reach the surface. The cross section of the semi-rigid bladder ring 3004 allows for the bladder 3002 to be shortened by a rolling technique as shown by the arrows in FIG. 143C. This not only shortens the bladder 3002 as shown in FIG. 143C, but also aids in wound retraction. The second bladder ring 3040 located at the lower center of the bladder 3002 acts as an anchor to allow maximum retraction of the wound opening. This allows for high access to the tissue 3006 by the morcellator. The bladder 3002 performs both containment and retraction functions. Once the wound is retracted, the air channels 3008 can be inflated as shown in FIG. 143D, with the optional tissue guard 200. The air channels 3008 expand outwardly and create a free space around the tissue 3006. This allows the tissue 3006 to be located in the free space. Being located in the free space allows the tissue 3006 to roll and move as it is being morcellated. Once the bag is in place, morcellation can begin. Once a sufficient amount of tissue 3006 has been removed, the bag 3002 can then be removed from the patient. In another form, the base of the bag 3002 can also be inflatable, for example as described above with reference to FIGS. 140 and 141.

144A-144C and 145A-145D, another form of containment bag 3002 having an inflatable sidewall is shown that does not include a second bag ring 3040, but only includes a first bag ring 3004. The bag 3002 has an open top with a semi-rigid first bag ring 3004 attached at the top. The bag 3002 utilizes air channels 3008 to aid in the expansion of a lower portion of the bag 3002 containing a specimen 3006. The air channels 3008 are disposed circumferentially around the circumference of the bag at the lower portion of the bag. The air channels 3008 are interconnected and connectable to an inflation pressure source. A positive inflation pressure acts to inflate the channels and a negative pressure acts to actively deflate the channels 3008. The deflated configuration is shown in FIG. 145A, and the inflated configuration is shown in FIG. 145B-D. In one configuration, the most proximal air channel, the air channel closest to the opening of the bladder, is annular and larger than the other air channels. The air channel 3008 is a tubular ring-shaped lumen that may be configured to be fluidly coupled with one or more adjacent tubular ring-shaped lumens and connectable to an inflation fluid source. This first proximal annular ring-shaped air channel lumen provides a counteracting force on the underside of the abdominal wall to allow for a large amount of retraction when the upper bladder ring 3004 is being rotated down on itself, thereby creating retraction. Thus, the first annular ring-shaped lumen acts similarly to a second bladder ring 3040 of the same configuration. Also, by expanding the lower portion, the visibility of the specimen 3006 from the apical side is greatly enhanced. This also helps to increase the speed at which morcellation can be performed. The bag 3002 is attached to a forked delivery shaft 3038. The forks are semi-rigid. The purpose of the delivery shaft 3038 is to allow the bag to be manipulated with great precision and with great ease. The system can be deployed in the abdomen by a trocar. The specimen 3006 is placed into the bag 3002, which is then retrieved through the abdominal wall. To retrieve the bag 3002, the forked shaft is pulled through the trocar until a corner of the bag is in the trocar. Once the bag 3002 engages the trocar, it can be pulled up to the surface. The entire bag does not pass through. The semi-rigid bag ring 3004 and a portion of the bag side wall are the only parts that reach the surface as shown in Figures 145A-145D. Once at the surface, the delivery shaft can be removed from the semi-rigid bag ring 3004. The cross section of the semi-rigid bladder ring 3004 allows for the bladder 3002 to be shortened by a rolling technique as shown by the arrows in FIG. 145D. This rolling action not only shortens the bladder 3002 by rolling the side walls of the bladder, but also aids in wound retraction. The bladder 3002 is then inflated. The bladder 3002 may be inflated prior to rolling as shown. The first annular air channel 3008 located at the bottom center of the bladder acts as an anchor to allow maximum retraction of the wound opening. This allows for increased access to the tissue by the morcellator. The air channel 3008 expands outwardly, creating a free space around the tissue 3006. This allows the tissue 3006 to be located in the free space. Being located in the free space allows the tissue 3006 to roll and move as it is being morcellated. Once the bladder 3002 is in place, morcellation can begin. Once a sufficient amount of tissue 3006 has been removed, the bag 3002 can then be removed from the patient. In another embodiment, the base of the bag 3002 can also be inflatable, for example as described above with reference to FIGS. 140 and 141.

A wide variety of materials can be used for the bladder and semi-rigid ring. It may be desirable to use multiple materials in the same bladder, such as a hybrid of polymer and woven fabric. The semi-rigid ring can be made from a number of soft polymeric materials, including but not limited to pellethane, silicone, KRATON polymer, IROGRAN polyester-based thermoplastic polyurethane, metals, polymers, plastics, rubber, etc.

Any of the containment bags described herein, including the inflatable bag 3002, may be used with a guard or shield configured to be positionable within the bag 3002 to protect the bag sidewalls and adjacent tissue edges from sharp manual or powered morcellation instruments. Additional examples of guards are shown in FIGS. 146-148. FIGS. 146A and 146B show a cylindrical rigid guard 3047 having a circular proximal end 3048 and a funnel-shaped distal end 3050 that flares outward. The funnel-shaped guard 3047 acts to funnel or funnel the tissue toward the cutting blade. The central lumen of the guard 3047 expands in the distal direction. The funnel shape also helps to expand the sidewalls of the bag 3002, thereby creating clearance for morcellation and preventing the specimen bag from hitting the blade. The guard 3047 may further include a spring loaded guard feature that prevents the blade from being exposed when not engaged with tissue. This allows for safe handling of the morcellator. The blade guard may be adapted to work in conjunction with the spring loaded guard.

148A and 148B, the guard 3047 has an inverted funnel or retract guard at its distal end with a central lumen that narrows toward the distal end 3050. The retract guard 3047 allows for easy coring of the tissue 3006. The blade guard 3047 is cone-shaped with a narrow end 3050 facing in the same direction as the leading edge of the morcellation tool blade. The guard 3047 pushes the surrounding tissue apart and to one side once the blade engages the surrounding tissue 3006.

147A and 147B, another form of guard 3047 is shown having anti-rotation studs 3052 extending from the inner surface of the guard 3047 into the central lumen. The inwardly projecting anti-rotation studs 3052 prevent the massed tissue 3006 from getting caught in the rotating blade and tube when a powered morcellator is used. When the tissue 3006 rotates with the blade, there is no relative blade motion and therefore the blade does not cut the tissue. The anti-rotation studs 3052 may be provided on the exterior of the studs 3052 that extend outward from the outer surface of the guard 3047. These protrusions stop the guard 3047 from rotating. The internal anti-rotation studs 3052 also help guide and direct the tissue 3006. The studs 3052 can have a variety of shapes and sizes. This feature can be adapted to work with any guard. In another embodiment, a bipolar vertical tissue separator can be provided in the guard. The bipolar vertical tissue separator feature functions to cut the core of tissue from the mass. This alleviates the problem of not being able to separate the cored and morcellated core from the larger mass. This feature can be adapted to cooperate with any blade guard. A light can also be provided with the guard 3047 and can be integrally formed therewith. The purpose of the light source, e.g., an LED, is to enhance and improve visibility within the tissue pouch 3002 for enhanced scope visibility. This feature can be adapted to cooperate with any blade guard. The embodiment of Figs. 147A and 147B further includes a number of holes 3054 extending across the guard 3047. These holes 5054 serve as vacuum bypass holes 3054 configured to prevent the pouch 3002 from being drawn into the blade when the tissue 3006 is pulled from the pouch 3002 using a vacuum, e.g., by a vacuum powered morcellation system. This is accomplished by providing exposed radial holes 3054 around the guard 3047 at all times. Once the blade is engaged with tissue, the vacuum bypass holes will not adversely affect the vacuum interface with the tissue. This feature may be adapted to work with any blade guard used under vacuum.

Morcellation is performed manually by the surgeon using a scalpel or electrosurgical instrument. Rather than utilizing a powered morcellator, any type of pouch described herein is used with the manual morcellation method. The pouch is inserted through the incision into the body cavity. The target tissue is placed into the pouch and the pouch opening is pulled through the incision. A pouch guard of the type described herein is inserted into the pouch and held near the pouch opening and optionally coupled to the proximal end of the pouch so that the pouch opening is held in an open position. The surgeon grasps the tissue with a grasper and pulls it toward the opening and places it in the guard placement location. The surgeon then cuts the tissue into small pieces using a scalpel rather than a powered morcellator and pulls the pieces out of the body. The cutting is performed at and/or against the guard placement location so that the pouch is not accidentally punctured by the scalpel. The pouch with small pieces of tissue or no tissue at all is removed from the body cavity along with the pouch guard.

The system includes a specimen collection container bag 3002 attached to the shaft. After the bag 3002 is deployed in the body to ablate the desired tissue 3006, the bag can capture the desired tissue 3006. Once the specimen 3006 is placed in the bag 3002, the semi-rigid ring 3004 attached to the bag opening can be pulled out of the body through the laparoscopic wound, incision, opening, or body access site. After the bag opening ring 3004 is pulled out of the patient's body, the lower bag portion remaining in the body cavity with the specimen 3006 has air channels 3008 that are inflated to create a structure that acts as an internal anchoring mechanism for the bag 3002 against the internal pneumoperitoneum pressure. The outer bag opening ring 3004 is then rotated down on itself to retract the wound opening in the same manner as described above. The inflated portion of the bag 3002 remaining in the body cavity with the specimen 3006 is now exposed to the surface. Once the specimen bag 3002 is retracted into place, a morcellator 3000 with a central hollow rotating blade tube 3010 is attached to the bag opening ring. The morcellator 3000 is locked in a stationary position with the blade tube 3010 inserted down through the wound and into the lower region of the bag 3002 containing the specimen 3006. At that point, the morcellator 3000 is turned on to allow the blade tube 3010 to rotate. Once the tube 3010 has rotated, a tenacious hook 3012 is inserted through the hollow rotating blade tube 3010 to grasp tissue and pull it up into the rotating blade tube 3010, which divides the large specimen 3006 into small core pieces that can be removed through a small laparoscopic wound site. The morcellator 3000 also has a camera 3014 located at the distal end of the morcellator 3000 to visualize the interior of the specimen bag 3002. Once the tissue 3006 has been completely removed or reduced in size enough to be pulled through the wound site, the morcellator 3000 is removed from the bag ring, the bag 3002 is deflated, and finally the bag 3002 is pulled through the laparoscopic wound and the procedure is complete.

149, a system is shown including a motorized morcellator 4000 and a bag 4002 coupled to the side of the morcellator shaft 4004. With further reference to FIGS. 150A-150D, the morcellator 4000 includes a handle 4006 coupled to the shaft 4004, with one or more rotating blades 4008 at the distal end of the shaft 4004. The morcellator 4000 further includes a motor 4010 disposed within the handle 4006. The motor 4010 is coupled to and configured to rotate a gear pinion 4012. The gear pinion 4012 is further coupled to a gear train including an inner gear tube 4014 and an outer gear tube 4016. The outer gear tube 4016 is further coupled to a spacer 4018, which is coupled to an outer shaft 4020. The distal end of the outer shaft 4020 is connected to the blade 4008. The gear inner tube 4014 is connected to the inner shaft 4026, which is connected to the second blade 4022. The gear outer tube 4016 and the gear inner tube 4014 are configured to counter-rotate to create counter-rotating blades at the distal end. In counter-rotating tubes, there are two tubes, one inside the other. The inner tube rotates in one direction and the outer tube rotates in the opposite direction. In one form, the blade is attached to the end of the outer tube. The idea of counter-rotating tubes is to double the relative velocity experienced by the tissue compared to the overall view of the blade. Whatever the tube configuration, this may have the outermost tube retaining the blade guard configuration. In another form, the inner tube is stationary relative to the rotating outer tube. The outer tube has a blade attached at its end, which is adapted to rotate. The idea of the stationary inner tube is to create a smooth member that allows for easy tissue advancement up the working channel. In another embodiment, a single outer tube rotates and there is only one tube with a blade attached at the end. The interior of the tube is featureless and smooth. In another embodiment, three tubes are provided, with the inner and outer tubes stationary and the middle tube rotating. The blade is attached to the end of the middle rotating tube, which extends beyond the inner and outer tubes. The stationary outer tube is to protect anything from being rubbed by the rotating middle tube. The stationary inner tube is to facilitate easy tissue advancement up the tube. In another embodiment, a corrugated tissue advancement tube is provided in any tube configuration that rotates and contacts tissue on its inner surface in an unimpeded manner. A corrugated pattern is formed on the inner surface of the rotating tube, and the corrugated tube exerts an axial force on the morselized tissue, which advances the tissue upwards and away from the blade. In yet another embodiment, an auger-type tissue advancement tube is provided for any rotating inner tube configuration. The tubes have multiple grooves that run the length of the interior of the tube. The ends of the grooves grip the tissue and advance it up the grooves and away from the blade. As can be seen in FIG. 150C, the counter-rotating tubes 4020, 4026 are driven from a single gear 4012, and an overmolded or quadring seal 4046 is provided to seal the tubes as shown in FIG. 150B. The electric motor is entirely contained within the handle 4006 and may be battery powered or connected to an external power source.

A spring loaded blade guard 4024 operates to cover and expose the blades 4008, 4022, and a trigger 4028 operates to activate the motor 4010. The spring loaded blade guard 4024 operates to expose only the blade 4008 once tissue contacts the end of the blade guard for added safety. The shaft of the blade guard 4024 with the opening and proximal portion may be removable, and the blade guard 4024 may be non-rotatable. The inner shaft 4026 and the outer shaft 4020 are concentric and define a working channel 4030 below the mid-portion. At the proximal end, a conical funnel 4032 is provided to facilitate insertion of an instrument, such as a grasper, into the working channel 4030. The proximal end of the morcellator 4000 may also be configured to be connected to a specimen container 4034 as shown in FIG. 151 and a vacuum source for removal of the morcellated specimen. The specimen container 4034 is a transparent container having an inlet port 4038 and a port 4040 on a removable lid that can be connected to a vacuum source. The port 4040 connected to the vacuum source can have a valve to turn the vacuum on or off, and can be configured to be electronically actuated. The proximal end of the morcellator 4000 is also configured to be connected to a seal assembly 4042 as shown in FIG. 150D. The seal assembly 4042 can include a zero seal and a septum seal that seals against an instrument inserted into an opening at the proximal end of the seal assembly 4042. The seal assembly 4042 can further include a port 4044 that can be connected to a source of fluid under pressure. The blade guard 4024 has at least one side slot or side window opening 4036 configured to expose the blade through the side to receive tissue to be morcellated through the side of the morcellator 4000 and into the working channel 4030. The blade guard 4024 can be rotated or retracted to cover and close the side opening or to expose the blade at the distal opening to receive tissue to be minced into the working channel 4030 at the distal end opening.

152, the following describes a pouch 4002 configured to be attached to a morcellator shaft 4004 with a side opening 4036. In one form of the pouch 4002, the pouch 4002 has an open top 4048 with a closure 4050. The morcellator shaft 4004 has a rounded end, which is adapted to be coupled to the pouch 4002. The side of the morcellator shaft 4004 has a window-like opening 4036. The specimen collection system is introduced into the body, for example, via a trocar or via an open wound or body orifice. The pouch 4002 is then opened and the tissue specimen is placed into the pouch 4002. The pouch 4002 is then sealed with a closure 4050. The morcellator shaft 4004 can be attached to the morcellator 4000, and morcellation begins. Alternatively, a bag tube 4066 is provided and the morcellator 4000 is easily attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in Figs. 152 and 159. The bag 4002 may be pre-attached to the bag tube 4066. Once the sample is reduced, the sample collection system is removed from the patient. An example of a morcellator is described in U.S. Patent Application Nos. 12/102,719 and 13/659,462, filed April 14, 2008 and October 24, 2012, respectively, which are incorporated by reference in their entireties as if set forth herein.

Various bag closure means will now be described with reference to Figs. 153-157. In Figs. 153A and 153B, a drawstring 4052 located at the bag top 4048 is used to close the open top 4048. In Figs. 154A and 154B, a ziplock or zipper style closure 4054 is provided, in which a slider is used to lock and unlock two sides of the closure to open and close the top 4048. In Figs. 155A-155C, another closure means includes a grommet 4056 formed in the bag 4002 near the bag top 4048. A grasper 4058 or other instrument is inserted into the opening of the grommet 4056 to open it, and then twisted to roll the bag 4002 down to close the open top 4048, as shown in Fig. 155C. In Figs. 156A and 156B, the top 4048 includes a hook and loop fastener 4060. Opposite sides of the hook and loop fastener are brought together to close the open bag top 4048. In Figs. 157A and 157B, the bag top 4048 includes a plurality of grommet openings 4062. Specifically, four openings 4062 are provided. For example, an instrument, such as a grasper 4058, is used to grasp all of the openings 4062, and then the grasper is twisted to roll the openings closed as shown in Fig. 157B.

158A-158E, a plastic guard 4064 is provided to protect the bag 4002 and prevent it from entering the side slot 4036 in the morcellator shaft 4004 and contacting the rotating blade 4008. The plastic guard 4064 is made of a single piece of semi-rigid plastic that is configured to be folded and inserted into the morcellator slot 4036. The plastic guard 4064 is made of a material that is more rigid than the bag 4002 and is configured to surround the side opening 4036 and provide a trough or funnel-shaped opening to spread the bag 4002 away from the opening 4036. The bag 4002 is attached to the distal end of the morcellator shaft 4004. The bag 4002 has an open top 4048 with a closure means 4050. The bag 4002 is provided at the side opening 4036 of the morcellator shaft 4004 and has a semi-rigid structure that allows tissue to be easily placed into the bag 4002. The specimen retrieval system is introduced into the body via a trocar or open wound or body orifice or other delivery mechanism. The bag 4002 is then opened and the tissue sample is placed into the bag 4002. The bag 4002 is then sealed with a closure 4050. The morcellator 4000 is attached to the proximal end of the morcellator shaft 4004 and morcellation begins. Alternatively, a bag tube 4066 is provided and the morcellator 4000 is attached to the bag tube 4066 by sliding the morcellator shaft 4004 into the bag tube 4066 as shown in FIG. 159. The bag 4002 may be pre-attached to the bag tube 4066 with or without a plastic guard 4064 or reinforcing rigid section provided near the distal opening of the bag tube 4066. The morcellator shaft 4004 and the bag tube 4066 are held together by friction by a knob attached to the bag tube 4066. The knob has an interference fit with the morcellator handle in a snap-fit or friction-fit engagement. Once the specimen is reduced, the specimen retrieval system is removed from the patient. The semi-rigid structure of the guard 4064 may be made of spring steel, nitinol, or molded plastic. All three configurations of material allow for closure of the bag 4002 by using a drawstring method or by pinching the ends and rolling the bag structure to close the bag 4002. In another configuration shown in FIG. 160, the bag 4002 is attached to the bag tube 4066. The bag 4002 has a closed end. An opening 4068 of the bag 4002 is provided on the side of the bag 4002. The bag 4002 further includes a semi-rigid structure at the opening to facilitate placement of tissue into the bag. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a windowed section 4070. The specimen retrieval system is introduced into the abdomen via a trocar or open wound. The bag 4002 is then opened and the tissue specimen is placed into the bag 4002. The bag is then sealed and the morcellator 4000 is attached and morcellation begins. Once the specimen is reduced, the specimen retrieval system is removed from the patient. The side opening 4068 may have a spring steel, nitinol or molded plastic reinforcement located in the middle of the side wall of the bag 4002. The side opening 4068 springs open to an oval shape, thereby facilitating tissue insertion of the specimen into the bag 4002. With all three configurations of material, the bag is closed by using a drawstring method or by pinching the ends and rolling the structure to close the bag 4002. Alternatively, spring steel, nitinol or molded plastic may be provided adjacent the bag tube 4066 as shown in FIG. 161.

In another embodiment shown in FIGS. 162A-162C, the bag 4002 is a separate component from the bag tube 4066. The bag 4002 has two open ends 4072, 4074. One opening 4072 is larger in diameter than the other. The larger end 4072 is semi-rigid with spring steel, nitinol or a plastic material. Various closure means 4050, such as a drawstring 4052 or a pinch and roll down method, can be used to seal the larger end 4072 of the bag 4002. The smaller end 4074 has a spring steel or nitinol clamp 4076 attached to the bag tube 4066. The clamp 4076 is attached around the rigid blade guard 4064. The taper of the rigid blade guard 4064 helps to keep the clamp 4076 from seating on the rim and sliding off the bag tube 4066. The bag tube 4066 has a rounded end. The side of the bag tube 4066 has a windowed section 4070. First, the bag 4002 is passed through an opening, body orifice, or open wound and introduced into the abdomen by a trocar, delivery shaft, instrument, or other deployment method. The larger end 4072 of the bag is then opened and placed around the tissue sample 4078. The larger end 4072 of the bag 4002 is then sealed. The bag tube 4066 is then introduced into the body. The bag 4002 is then attached to the bag tube 4066 by a clamp 4076. The morcellator 4000 is attached and morcellation begins. Once the specimen 4078 has been reduced, the collection system is removed from the patient.

In another embodiment shown in Figs. 163A-163C, the bag 4002 is attached to a bag tube 4066, called a bag tube. The bag 4002 has an open end. The bag tube 4066 has a rounded end. The bag tube 4066 has an oversheath. The tip of the sheath has two holes that facilitate manipulation of a Nitinol or other flexible semi-rigid drawstring 4052 to open and close the semi-rigid bag opening 4068. The sheath also has two channels parallel to the axis of the tube to facilitate retrieval of the Nitinol. The side of the tube has a windowed section 4070. A specimen retrieval system is introduced into the body through the opening as shown in Fig. 163B. The bag 4002 is then opened by loosening the drawstring 4052, and the tissue specimen 4078 is retrieved by enclosing the tissue specimen 4078 in a net created by the Nitinol and the bag 4002. This can be done with or without the aid of a grasper or dissector. Once the tissue 4078 is enclosed, the nitinol can be retrieved proximally by the drawstring 4052, which closes the bag 4002 around the tissue sample 4078, sealing the bag 4002. The morcellator is attached and morcellation begins. Once the specimen 4078 is reduced, the retrieval system is removed from the patient.

In another form, the bag 4002 has an open top with a semi-rigid ring attached at the top. The bag 4002 can be tightly rolled and then deployed into the abdomen via a trocar. The bag 4002 is then opened internally by manipulation with a grasper. The specimen 4078 is placed into the bag 4002 and the bag 4002 is retrieved through the abdominal wall. The entire bag 4002 does not pass through. The semi-rigid bag ring is the only part that reaches the surface while the rest of the bag remains within the abdominal cavity of the body. Morcellation can begin. Once a sufficient amount of tissue 4078 has been removed, the bag 4002 can then be removed from the patient.

The tissue guards described herein are typically used with a containment bag. The bag is placed into the body through a body opening. A body opening refers to any entryway into the patient, which may include, but is not limited to, an incision site and a natural body orifice. The target specimen is generally too large to be safely removed through the body opening and must be manipulated, for example, by cutting with a blade, in order to remove the target specimen through the body opening. Minimally invasive laparoscopic body openings are generally smaller than the target specimen size. The target specimen is placed into the bag and the mouth of the bag is pulled outside the patient's body. The guard is placed into the mouth of the bag and seated across the body opening, drawing the target specimen into the lumen of the guard. While in the lumen of the guard, the target specimen is in a protective morcellation zone in which the surgeon uses a blade to reach and removably sever the target specimen. The guard provides protection against stray blades and also provides a direct cutting surface against which tissue can be placed for reduction. The overall length of the guard defines the length of the morcellation zone that protects the pouch and tissue at the margin of the body opening. In addition, a retractor can be used. The retractor can be integrally formed with the pouch or can be a separate stand-alone device. The exemplary retractor described herein is a two-ring retractor with a flexible sidewall material disposed between the two rings. The sidewall of the retractor is configured to be wrapable around the first ring to retract tissue at the margin of the body opening. When a retractor is used, the retractor can be placed within the pouch, between the marginal tissue and the pouch or between the pouch and the guard. The above description relates to various uses of the guard, pouch and retractor used in manual morcellation methods. In the case of powered morcellation methods, the guard is inserted into the pouch and morcellation is performed. In another embodiment for powered morcellation, a stabilizing cap is connected to the proximal ring of the pouch or the proximal end of the guard, and powered morcellation is performed. The stabilizing cap helps to define the vertical position of the blade, so that the blade does not extend beyond a predefined morcellation zone within the guard or a short distance safely beyond the distal end of the guard. In another embodiment for powered morcellation, a retractor is used, in this case placed between the marginal tissue and the pouch, or between the pouch and the guard as described above, and powered morcellation is performed. In the previous embodiment, a stabilizing cap can be used that is connected to the proximal ring of the retractor, the proximal ring of the pouch, or the proximal end of the guard, and morcellation is performed. In addition to the above embodiment, when performing a procedure such as a hysterectomy, any one of the following approaches can be used in conjunction with any of the above embodiments. In one form, the bag is placed inside the body through the vagina, the target specimen (e.g., uterus) is placed inside the bag while it is in the body cavity, then the mouth of the bag is pulled through an abdominal incision, the guard is inserted into the mouth of the bag, and the morcellation, removal, and removal of the bag is performed at the abdominal opening. In another form, the bag is placed inside the body through the vagina, the target specimen (e.g., uterus) is placed inside the bag while it is in the body cavity, then the mouth of the bag is pulled back through the vaginal canal, the guard is inserted into the mouth of the bag, and the morcellation, removal, and removal of the bag is performed at the vagina. In yet another form, the bag is placed inside the body through an abdominal incision, the target specimen (e.g., uterus) is placed inside the bag while it is in the body cavity, then the mouth of the bag is pulled through the vaginal canal, the guard is inserted into the mouth of the bag, and the morcellation, removal, and removal of the bag is performed at the vagina. In another form, a pouch is placed inside the body through an abdominal incision, the target specimen (e.g., uterus) is placed into the pouch while it is in the body cavity, then the mouth of the pouch is pulled back through the abdominal incision, a guard is inserted into the mouth of the pouch, and morcellation, removal, and removal of the pouch is performed at the vagina. In another approach to morcellation of the uterus or other target specimen, the pouch may be omitted. In such a case, an incision is made in the abdominal wall, a guard is placed across the abdominal incision, the uterus or target specimen is dissected and pulled through the central lumen of the guard, and morcellation and removal is performed at the abdominal incision. Alternatively, the target specimen (e.g., uterus) is accessed vaginally, a guard is placed in the vaginal canal, the target specimen is dissected and pulled through the central lumen of the guard, and morcellation and removal is performed at the vagina. As an alternative form of abdominal access without a pouch, the procedure can be viewed with a laparoscope inserted through the vagina. As an alternative to pouch-free vaginal access, the procedure can be viewed with a laparoscope inserted through an incision in the abdomen.

In some cases, a guard is not used. In one such configuration in which a guard is not used, a pouch may be placed in the body cavity via the vagina, a target specimen may be placed in the pouch, the mouth of the pouch may be pulled back through an abdominal incision, a retractor may be placed in the pouch across the abdominal incision, and morcellation, removal, and pouch removal may occur at the abdominal incision. In another configuration in which a guard is not used, a pouch may be placed in the body cavity via the vaginal canal, a target specimen may be placed in the pouch, the mouth of the pouch may be pulled back through the vaginal canal, a retractor may be placed in the pouch in the vaginal canal, and morcellation, removal, and pouch removal may occur at the vagina. In another configuration in which a guard is not used, a pouch may be placed in the body cavity via an abdominal incision, a target specimen may be placed in the pouch, the mouth of the pouch may be pulled back through the vaginal canal, a retractor may be placed in the pouch in the vaginal canal, and morcellation, removal, and pouch removal may occur at the vagina. In another configuration where a guard is not used, a pouch may be placed in the body cavity via an abdominal incision, the target specimen may be placed in the pouch, the mouth of the pouch may be pulled through the abdominal incision, a retractor may be placed in the pouch in the vaginal canal, and morcellation, removal, and pouch removal may occur at the abdominal incision. For any of the configurations where a guard is not used and a retractor is used, it is preferable to use any of the cut-resistant retractors described above. Also, for any of the configurations where a guard is not used and a retractor is used, a retractor may be placed between the pouch and the tissue margin. Also, for any of the configurations where a guard is not used and a retractor or no retractor is used, it is preferable to use any of the cut-resistant pouches described above. Powered morcellation may also be used with any of the methods where a guard is used. In such cases, a stabilizing cap is used to connect to the proximal end of the bag or the proximal ring of the retractor.

In a configuration in which the retractor is used without a guard, a cut-resistant retractor is provided. The retractor has a first ring and a compressible second ring connected together by a webbing or sidewall. The retractor is configured such that the webbing can be wrapped around the first ring, thereby reducing the length of the retractor and retracting the tissue margins. The bottom ring is inserted through the body opening and is located within the patient's body while the top ring of the retractor is located above the patient. The top ring is turned/flipped over itself like a bag to draw the lower ring of the retractor closer and the sidewalls into a taut relationship between the rings. The lower ring of the retractor advantageously retracts the portion of the bag within the patient's body to avoid potential damage caused by puncture and tearing by the blade. At least a portion of the webbing is made of a puncture-resistant and cut-resistant material. The retractor is configured to be inserted into the containment bag and into the body opening to retract the bag and tissue margins, with a first ring of the retractor and the mouth of the containment bag located outside the patient's body, and a second ring of the retractor and the remainder of the containment bag located inside the patient's body. This positioning of the bag between the retractor and the tissue margins at the body opening anchors the bag to the patient's body. In one form, only a distal portion of the webbing, approximately 4 inches (10.16 cm) long, is cut resistant and is made of KEBLAR, DYNEEMA or other cut resistant material, while a proximal portion of the webbing is not made of a cut resistant material and is made of polyurethane or other soft film. This configuration allows the proximal end of the webbing to be easily wrapped around the first ring during retraction. When the length of the webbing is reduced by rolling it, the distal cut-resistant portion of the webbing is brought closer to the proximal end or first ring of the retractor and into position to protect the morcellation to be performed. With less cut-resistant material, which may be thick and bulky, the retractor is less expensive and easier to turn over and rotate the first ring because the less cut-resistant material is wrapped around the first ring. In another form, the entire webbing is made of a cut-resistant material. In another form, for example for intravaginal use, only the proximal portion of the webbing, about 5 inches (12.70 cm) long, is cut-resistant and is made of KEBLAR, DYNEEMA or other cut-resistant material, and the distal portion of the webbing is not made of a cut-resistant material but is made of polyurethane or other soft film to increase flexibility and allow anchoring at the proximal end. In vaginal surgical procedures, such as a total laparoscopic hysterectomy, the first ring at the proximal end does not need to roll down on itself to the same extent. Therefore, the proximal end of the webbing is made of a cut-resistant material compared to abdominal surgical procedures, where the webbing is wrapped around the first ring much less and the proximal end is not made of a cut-resistant material.

According to one aspect of the present invention, a contamination prevention system for manual or powered field morcellation is provided. The system includes a containment bag having an aperture and a shield configured for removably insertion into the aperture of the bag. The shield has a central lumen that provides a working channel for morcellation and protects the bag and surrounding tissue.

In accordance with another aspect of the present invention, an instrument is provided for safely removing a tissue sample from a body cavity through a body opening smaller than the tissue sample. The instrument has a removable shield configured to be secured within the body opening. The instrument further includes a pouch or retractor disposed between the body opening and the shield.

In accordance with another aspect of the present invention, a shield is provided having side walls defining a central opening. The shield has a C-shaped concave outer surface that anchors the shield within the body opening.

In accordance with another aspect of the present invention, a shield is provided having side walls defining a central opening. The shield has a C-shaped concave outer surface that anchors the shield within a body opening. The shield is split such that one portion of the shield is nested within another portion of the shield, and the shield is expandable from a reduced lateral configuration to an enlarged lateral configuration by altering the nested portion of the shield, or vice versa.

In accordance with another aspect of the present invention, an expandable shield is provided having side walls defining a central opening. The shield is movable between a first configuration and a second configuration. The first configuration has a dimension that is greater than the dimension when in the second configuration, the dimension being a vertical and/or lateral dimension.

In accordance with another aspect of the present invention, a system is provided for preventing the potential spread of cancerous cells when removing a large tissue specimen through a small body opening. The system includes a container and a morcellation zone. The morcellation zone is insertable into and removable from the container. The morcellation zone protects the container from penetration by a morcellation instrument.

According to another aspect of the present invention, a shield is provided having a blade coupled to the shield. The blade is movable along a predetermined path relative to the shield, and the shield surrounds at least a portion of the predetermined path to protect tissue surrounding the body opening.

164-167, a shield 5000 of the present invention is shown. The shield 5000 has a band of soft, cut-resistant material. The shield 5000 has an inner surface 5002 and an outer surface 5004 interconnected by an apex end 5006, a bottom end 5008, a first end 5010, and a second end 5012. The band is configured to define a central lumen having a longitudinal axis. The central lumen has a lumen diameter perpendicular to the longitudinal axis. The lumen diameter may vary along the longitudinal axis. For example, the inner surface 5002 may be shaped, such as, for example, convex, and the central lumen may be larger at the apex end 5006 and the bottom end 5008 relative to the lumen diameter at the center or waist of the band as shown in FIGS. 164-167. In one form, the inner surface 5002 defines a constant lumen diameter from the apex 5006 to the base 5008 or assumes a chevron or funnel shape or other curve or shape. The outer surface 5004 is substantially conforming in shape to the inner surface 5002 to define a band of substantially uniform thickness, although the invention is not limited thereto and the outer surface 5004 can assume a different shape than the inner surface 5002 and/or have a different band thickness along the longitudinal axis. The curved, funnel or C-shaped, concave shape of the outer surface 5004 described hereinabove helps anchor the shield 5000 at the tissue margins when inserted into a body orifice, incision site or other opening. Additionally, the larger diameter shape at the apex 5006 helps provide a cutting board surface for performing manual morcellation and protecting the surrounding tissue. For example, a flat, planar orientation of the apex 5006 with the inner surface 5002 facing upward and perpendicular or nearly perpendicular to the longitudinal axis and the outer surface 5004 facing downward onto the tissue, e.g., onto the abdominal wall, creates a large protective overlay or a large cutting board-like surface. As shown in the configuration of Figs. 164-167, the outer surface of the band has a recess or curvature extending circumferentially around the guard from the apex 5006 to the bottom 5008 along the longitudinal axis. The shield 5000 is made of a soft, resilient material, e.g., plastic, and the shield is molded to have a rest configuration that defines a rest lumen diameter. The rest configuration is shown in Figs. 164-166, where a gap is created between the first end 5010 and the second end 5012. The gap is about 5-10° with an arc length of about 4-6 mm. The rest lumen diameter at the waist is about 40 mm. Because the shield 5000 is elastic and soft, its lumen diameter can be adjusted by bending the band inwardly and turning it on itself to reduce the gap, thereby overlapping the first end 5010 and the second end 5012 of the band and reducing the lumen diameter, or by bending the band outwardly and bending it on itself to increase the gap and increase the lumen diameter relative to the rest lumen diameter. Due to the increase or decrease in lumen diameter relative to the rest lumen diameter, the band tends to spring back toward approximately the rest configuration and rest lumen diameter due to its elasticity. In one form, the rest configuration does not have a gap. When the diameter of the band is reduced, the first end 5010 overlaps the second end 5012 to form a helical shape when viewed from above or below. The outer surface 5004 of the band at the first end 5010 faces at least a portion of the inner surface 5002 of the band at the second end 5012, such that the portion of the band near the first end 5010 telescopes within the portion of the band near the second end 5012. To receive the telescoped first end portion of the band, the second end portion is configured to inch outwardly a distance 5014 approximately equal to the width of the band wall, i.e., the width of material between the inner surface 5002 and the outer surface 5004, which is approximately 1-3 mm, such that when telescoped, the inner surface 5002 maintains a large inner diameter that is not reduced by the overlapping segments of the band where the overlap is located, yet at the intersection, the inner surface is substantially flush with the overlap location, as can be seen in FIG. 167. A ridge inner surface 5016 is formed in the shield 5000 by an outwardly extending jog or irregularity made on the inner surface of the band by the increase in lumen diameter. The increased lumen diameter extends from the ridge inner surface 5016 along a portion of the circumference of the band to the second end 5012. The inner ridge 5016 is formed from the second end 5012 for approximately 127°. The inner ridge 5016 is formed relative to the inner surface 5002 and extends substantially perpendicularly from the inner surface 5002 longitudinally from the apex end 5006 to the bottom end 5008. The inner ridge 5016 forms a corresponding outer ridge 5018 when the band is shaped to form a jog at the inner ridge 5016 where the band increases in inner diameter a segment distance 5014 of approximately 127° around the circumference from the inner ridge 5016 to the second end 5012. At least one abutment is formed between the inner ridge 5016 and the second end 5012 and extends along the longitudinal axis between the top end 5006 and the bottom end 5008.

A first inner abutment 5020 is formed on the inner surface 5002. The surface of the first inner abutment 5020 faces the second end 5012, and is substantially perpendicular to the inner surface 5002 and extends outward from the inner surface 5002 along the longitudinal axis between the top end 5006 and the bottom end 5008. The first inner abutment 5020 has a height from the inner surface 5002 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. When the first end 5010 overlaps the second end 5012 and faces the outer surface 5004 at the first end 5010 over the inner surface 5002 at the second end 5012 in the first reduced configuration, the first end 5010 is configured to contact the first inner abutment 5020 to lock the dimension of the inner diameter and prevent further reduction in this dimension. This configuration helps lock the shield 5000 in a fixed diametrical/lateral dimension position with the shield 5000 maintaining a certain number of degrees (°) of circumferential overlap around a portion of the circumference of the shield 5000. This lock is particularly useful when the shield 5000 is placed in an opening or incision where tissue forces tend to collapse the central lumen, further reducing the inner diameter. The central lumen serves as a working channel and the lock is created when at least a portion of the shield 5000 contacts the first inner abutment 5020. The first inner abutment 5020 is located approximately 30° from the second end 5012. When the first end 5010 contacts the first inner abutment 5020, the inner diameter is approximately 36 mm.

The shield 5000 further includes a second inner abutment 5022 disposed at a long distance from the second end 5012. In particular, the second inner abutment 5022 is disposed at approximately 65° from the second end 5012. The second inner abutment 5022 is formed on the inner surface 5002. The surface of the second inner abutment 5022 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outwardly from the inner surface 5002 along the longitudinal axis between the top end 5006 and the bottom end 5008. The second inner abutment 5022 has a height from the inner surface 5002 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. The first inner abutment 5020 and the second inner abutment 5022 are substantially parallel. When the first end 5010 overlaps the second end 5012 such that the outer surface 5004 at the first end 5010 faces over the inner surface 5002 at the second end 5012 in a reduced diametric/lateral configuration, the first end 5010 is configured to contact the first inner abutment 5020 or the second inner abutment 5022 to lock the inner diameter dimension and prevent further reduction in this dimension. The second inner abutment 5022, like the first inner abutment 5020, serves to lock the shield 5000 in a fixed diametric/lateral dimension position with the shield 5000 maintaining a certain number of degrees (°) of circumferential overlap around a portion of the circumference of the shield 5000. This lock is particularly useful when the shield 5000 is placed in an opening or incision where tissue forces tend to collapse the central lumen and further reduce the inner diameter. The central lumen serves as a working channel and the lock is created when at least a portion of the shield 5000 contacts the second inner abutment 5022. When the first end 5010 contacts the second inner abutment 5022, the inner diameter is about 33 mm. When the first end 5010 contacts the second inner abutment 5022, the first inner abutment 5020 is positioned against the outer surface 5004. A first outer abutment 5024 or receiving area 5024 is formed on the outer surface 5004 to receive the first inner abutment 5020. In one form as shown, the receiving area 5024 is formed with an abutment, and in another form, the receiving area is not configured to have an abutment surface. The first outer abutment 5024 is positioned about 30° from the first end 5010. The first outer abutment 5024 is formed on the outer surface 5004. The surface of the first outer abutment 5024 faces the first end 5010, the surface being substantially perpendicular to the outer surface 5004 and extending inwardly from the outer surface 5004 along the longitudinal axis between a top end 5006 and a bottom end 5008. The first outer abutment 5024 has a height relative to the outer surface 5004 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. The first outer abutment 5024, the first inner abutment 5020 and the second inner abutment 5022 are substantially parallel. When the first end 5010 overlaps the second end 5012 and the first end 5010 contacts the second inner abutment 5022, the first inner abutment 5020 faces and contacts the first outer abutment 5024, thereby locking the size of the inner diameter and preventing further reduction in this size.

The shield 5000 further includes a third inner abutment 5026 disposed at a long distance from the second end 5012. Specifically, the third inner abutment 5026 is disposed at approximately 100° from the second end 5012. The third inner abutment 5026 is formed on the inner surface 5002. The surface of the third inner abutment 5026 faces the second end 5012, is substantially perpendicular to the inner surface 5002, and extends outwardly from the inner surface 5002 along the longitudinal axis between the top end 5006 and the bottom end 5008. The third inner abutment 5026 has a height from the inner surface 5002 that is approximately equal to or greater than the thickness of the band material between the inner surface 5002 and the outer surface 5004. The first inner abutment portion 5020, the second inner abutment portion 5022, and the third inner abutment portion 5026 are substantially parallel and approximately equally spaced around the circumference of the inner surface 5002. When the first end 5010 overlaps the second end 5012 to face over and against the inner surface 5002 at the second end 5012 when the outer surface 5004 at the first end 5010 is in a reduced diameter/lateral configuration, the first end 5010 is configured to contact either the first inner abutment portion 5020, the second inner abutment portion 5022, or the third inner abutment portion 5026 to variably adjust the inner diameter and then lock the size of the inner diameter to prevent further reduction in this size. The third inner abutment 5026, like the first inner abutment 5020 and the second inner abutment 5022, serve to lock the shield 5000 in a fixed diametrical/lateral dimension position with the shield 5000 maintaining a certain number of degrees (°) of circumferential overlap around a portion of the circumference of the shield 5000. This locking is particularly useful when the shield 5000 is placed in an opening or incision where tissue forces tend to collapse the central lumen and further reduce the inner diameter. When the first end 5010 contacts the third inner abutment 5026, the inner diameter is approximately 30 mm. When the first end 5010 contacts the third inner abutment 5026, the first inner abutment 5020 and the second inner abutment 5022 are placed against the outer surface 5004. A first outer abutment or receiving area 5024 is formed on the outer surface 5004 and a second outer abutment or receiving area 5028 is formed on the outer surface 5004 for receiving the first inner abutment 5020 and the second inner abutment 5022. In one form, the receiving area comprises an abutment surface, and in another form, the receiving area is sized and shaped to receive the inner abutments flush. The second outer abutment 5028 is disposed approximately 65° from the first end 5010. The second outer abutment 5028 is formed on the outer surface 5004. The surface of the second outer abutment 5028 faces the first end 5010 and is substantially perpendicular to the outer surface 5004 and extends outwardly from the outer surface 5004 along the longitudinal axis between the top end 5006 and the bottom end 5008. The second outer abutment 5028 has a height from the outer surface 5004 that is approximately equal to or greater than the height of the inner abutment or the thickness of the band material between the inner surface 5002 and the outer surface 5004. The second outer abutment 5028, the first outer abutment 5024, the first inner abutment 5020, the second inner abutment 5022, and the third inner abutment 5026 are substantially parallel. When the first end 5010 overlaps the second end 5012 and the first end 5010 contacts the third inner abutment 5026, the first inner abutment 5020 faces and contacts the second outer abutment 5028, and the second inner abutment 5022 faces and contacts the first outer abutment 5024, thereby locking the size of the inner diameter and preventing further reduction in this size.

The shield 5000 further includes a third outer abutment 5030 that is disposed at a greater distance from the first end 5010 than the second outer abutment 5028. Specifically, the third outer abutment 5030 is disposed at approximately 100° from the first end 5010. The third outer abutment 5030 is formed on the outer surface 5004. The surface of the third outer abutment 5030 faces the first end 5010, is substantially perpendicular to the outer surface 5004, and extends inwardly from the outer surface 5004 along the longitudinal axis between the top end 5006 and the bottom end 5008. The inward extension of the outer abutment creates a ramp-like surface on the inner surface 5002. The third outer abutment 5030 has a height from the outer surface 5004 that is approximately equal to or greater than the thickness of the band or inner abutment. The third outer abutment portion 5030 is configured to correspond and receive the first inner abutment portion 5020 when the first end 5010 abuts the inner ridge 5016 as shown in Fig. 167. In another form, the first end 5010 abuts a fourth inner abutment portion that is not configured as an inner ridge 5016 as described herein. The first inner abutment portion 5020, the second inner abutment portion 5022 and the third inner abutment portion 5026 are substantially parallel. When the first end 5010 overlaps the second end 5012 such that the outer surface 5004 at the first end 5010 faces over the inner surface 5002 at the second end 5012 in the reduced diameter/lateral configuration, the first end 5010 is configured to contact either the first inner abutment 5020, the second inner abutment 5022, the third inner abutment 5026, or the inner ridge 5016 to variably adjust the inner diameter and lock the size of the inner diameter and prevent further reduction in said size. In one form, all of the inner abutments, including the inner ridge, are substantially equally spaced apart. The first end 5010 is shown in FIG. 167 contacting the inner ridge 5016 to form the shield 5000 with the smallest relative inner diameter of about 28 mm. When the first end 5010 contacts the inner ridge 5016, the first inner abutment 5020, the second inner abutment 5022, and the third inner abutment 5026 are disposed against the outer surface 5004, and in particular are received within or against the third outer receiving area or abutment 5030, the second outer receiving area or abutment 5028, and the first outer receiving area or abutment 5024, respectively. To unlock the shield 5000, the inner telescoping segment, i.e., the first end 5010, of the shield 5000 is moved toward the longitudinal axis to disengage the abutment surfaces from one another. The first end 5010 is bounded by a marker 5032, such as a tab, a grip with a patterned surface, or an area of contrasting color located, for example, near the top end 5006 or bottom end 5008, that serves as an indication to the user as to which end of the shield 5000 is fitted into the shield 5000 so that the abutments interlock accordingly. The marker 5032 also provides a patterned location to facilitate removal or release of the shield 5000 from the locked configuration by pulling or gripping the shield. The marker 5032 can further serve an orientation purpose to instruct the user which side of the shield is facing up if the shield is asymmetric along the longitudinal axis.

Although the three inner abutments 5020, 5022, 5026, the three outer abutments 5024, 5028, 5030, and the one inner ridge 5016 are described as having a certain spacing and angular relationship, the invention is not so limited and any number of inner abutments can be provided to provide a variable locking configuration to achieve a desired inner diameter of the working channel. Furthermore, although the gap is shown to be approximately 8° in the relaxed configuration, the invention is not so limited and the shield 5000 can have a larger gap, a smaller gap, or zero gap. As described above, the shield 5000 is designed such that the first end 5010 serves as an abutment, specifically a functional locking edge that contacts one or more of the inner abutments 5020, 5022, 5026 and/or one or more of the inner ridges 5016 at a time to variably select and fix the inner diameter. In another configuration, the first end 5010 does not serve as a functional edge, but instead serves as a functional locking edge when the outer abutment contacts and abuts one or more of the inner abutments 5020, 5022, 5026. And, in yet another configuration of the shield described above, the first end 5010 and one or more of the outer abutments 5024, 5028, 5030 serve as functional locking edges, where one or more of the abutments are in simultaneous contacting relationship at a fixed diametrical position. Each inner abutment forms a triangular shaped ramped protrusion from the inner surface 5002, and the outer abutment forms a correspondingly shaped, but larger, triangular shaped ramped recess or protrusion into the outer surface 5004 configured to receive the smaller inner abutment, such that one or more inner abutment surfaces are simply received within the receiving area with or without contacting one or more outer abutments. In one form, the shape of the inner and outer abutments may further include a friction or snap fit configuration to further enhance the locking function, where the feature includes a ridge that provides a lock, ledge or gate with increased friction. The ramped protrusion at the inner surface 5002 facilitates the expansion of the shield from the reduced configuration to the expanded configuration. For example, when inserting the shield into an incision/mouth, the shield 5000 may first be curled or rolled into a reduced configuration so that the shield 5000 can fit into a small incision/mouth, and then the shield 5000 may be stretched to a larger diameter configuration. As the reduced configuration is stretched to a larger diameter configuration, portions of the outer surface 5004 ride upwardly over the ramped protrusions on the inner surface 5002. After the outer surface has been run over the inner surface, the inner abutment contacts the outer abutment to create a first stop or locked position. The shield 5000 is then further stretched, causing the outer surface to ride over the inner protrusions at the location of the outer abutment to another locked position, where the inner and outer abutments contact each other, and so on. Thus, the expansion of the shield is performed in a ratchet fashion, where the diametric dimension gradually increases in steps between locking interactions with one or more abutments. In one form, the shield 5000 does not have an outer abutment formed on the outer surface. Instead, the shield 5000 has a receiving area that receives an inner abutment that the outer surface covers to provide a flush locking position, and the locking function is performed when the inner abutment contacts the first end 5010 or, in one form, one or more outer abutments formed on the receiving area. Thus, the receiving area that is not configured for an abutment formed on the outer surface 5004 can assume any shape at the outer surface. The inner surface at the opposite location from the receiving area can have a beveled or other curved form that facilitates movement of the shield between the contracted and expanded configurations. This beveled feature advantageously makes the shield 5000 easier to use, since a separate step is not required to mechanically unlock the locked configuration when the shield is stretched to a larger diameter state. Instead, the shield is simply curled or otherwise moved circumferentially so that it ratchets over the inner projection into a locked position adjacent the abutment.

The shield 5000 shown in Figs. 164-167 is adjustable to have four separate inner diameter sizes. When inserted into an incision or body opening, the shield 5000 provides protection and can fit into incisions of about 1 inch (2.54 cm) or less. Of course, larger shields 5000 can be made to be placed into larger incisions/openings, such as the vaginal canal. Such shields can also be made to have lengths longer than those shown in Figs. 164-167. The shield 5000 allows for retraction of tissue at the incision/opening. When inserted into the incision/opening, the shield 5000 curls into a reduced configuration, thereby inserting into a smaller incision/opening, and then stretches out the shield 5000 into a larger diameter configuration with multiple locking positions that can be utilized to customize the locking position of the shield. Thus, the shield 5000 helps perform the function of retraction, enlarging the incision or opening as the shield diameter and working channel expand. With the shield 5000 of FIGS. 164-167, the shield allows for retraction and can conform to incisions up to about 1.5 inches (3.81 cm) in diameter. Retraction of the surrounding tissue provides more working space and better stability for the user.

Additionally, the locking mechanism of the shield 5000 is unique because it utilizes radial pressure exerted from the outside on the shield 5000 and the outer surface 5004. Thus, the shield, and in particular the locking mechanism of the shield, in one form, functions when the shield is inserted into an incision of a size equal to or smaller than the inner diameter of the shield in its most reduced form. The surrounding tissue exerts a radial force circumferentially around the outer periphery of the shield 5000, which causes the first end 5010 to abut against one or more of the inner abutments or inner ridges and/or the one or more inner abutments to abut against one or more outer abutments. The surrounding tissue edges exert a compressive force on the shield. The shield is configured to utilize a force component that is tangential to the periphery of the shield, thereby moving both the inner and/or outer and/or ridges and/or first ends of the vertical abutments to contact one or more other abutments or ridges, first ends or other vertical structures, thereby preventing the shield from collapsing while providing a locking feature. The structures of the shield perpendicular to the circumferential surface, e.g., abutments/edges/ridges, provide support and reinforcement to the structure, making the shield stronger. The configuration of the shield having a locking position and configuration where two or more pairs of abutment surfaces are in contact simultaneously to strike the locking position allows the shield to be stronger and able to withstand forces that tend to disrupt the position of the retracted tissue. To retract tissue and further increase the radial strength of the shield while under tissue pressure around the shield when in the tissue opening, any one or more of the abutments/ridges/edges forming the contact surfaces which perform the locking function extend from at or near the apex 5006 to at or near the base 5008 or a length at least equal to or greater than 50 percent surface length of the shield in order to provide strength and substantially uniform reinforcement along the length of the shield from apex to base. Tissue pressure on the shield while it is in the incision/mouth will force the leading edge and outer abutments into the corresponding inner abutments and the overlapping faces of the shield can sit flush within the shield due to the ridges and jogs formed on the shield, the distance of the ridges or jogs being equal to the width of the shield wall. In the absence of tissue pressure on the shield, the shield, which is brought to a reduced configuration with the surfaces abutting each other, does not remain in the reduced and locked configuration because the shield is shaped and biased toward the larger rest configuration. Thus, the lock is an integral lock that requires tissue pressure to achieve the locked configuration in one form. Tissue pressure at the location of the incision/mouth cooperates to bring the abutting surfaces into and maintain them in the locked configuration. In use, the shield is brought from the rest configuration to the reduced configuration by first closing the gap and bringing the first end of the band into an overlapping configuration with at least a portion of the second end of the band. To increase the overlap, the band is curled downwards to further reduce the inner diameter to a size that fits within the incision/mouth. The shield is inserted into the incision/mouth, released within the incision/mouth, and subjected to pressure from the surrounding tissue resulting from a smaller incision/mouth diameter than the reduced configuration of the shield or by increasing the size of the shield by stretching the shield from the reduced configuration. The shield is curled back to increase the inner diameter of the shield. Increasing the inner diameter tends to retract the tissue at the margins of the incision/mouth. Tissue retraction increases the bias of the tissue back onto the shield. Reducing the amount of overlap of the shield causes the abutments to ratchet into successively positioned locked positions where one or more abutments are in contact with each other or with an edge or ridge. Contact with the abutments prevents the shield from collapsing and fixes the inner diameter. Viewed from above along the longitudinal axis of the shield, the shield will assume a helical shape in a plane perpendicular to the longitudinal axis when in the contracted configuration. When in the rest configuration, the shield forms an open circle or an open oval in one configuration. In another configuration, the first end of the shield slightly overlaps the second end of the shield. A locking mechanism in cooperation with tissue pressure helps to anchor the shield in the incision/mouth. The bold C-shaped curvature of the outer surface is not necessary to help anchor the shield in the incision/mouth for the lock. If the lock is not used, forcing the lower flange of the bold C-shaped outer surface into the incision/mouth and resting the upper flange against the tissue surface helps anchor the shield to the patient. The locking mechanism advantageously allows the working channel and inner diameter to be maximized, where the working channel and inner diameter are reduced to the sidewall of the band by the bold C-shaped curvature. In one form, the shield has no curved profile or only a very slight curved profile to maximize the inner diameter since it relies heavily on the locking mechanism to anchor the shield to the patient. The outward jog at the second end of the band further maximizes the inner diameter where one portion of the band overlaps another portion of the band, resulting in a uniform and same inner diameter rather than the inner diameter being reduced where the overlap is located. In one form, the shield does not have an outer abutment, but instead has a receiving area sized and shaped to receive the inner abutment when the shield is spiraled to overlap the inner abutment. The receiving area prevents the overlapping band from bending inward toward the central lumen. Instead, the inner abutment is received within the receiving area to maximize the inner diameter and create a flush arrangement of the band around the inner circumference even where there is an overlapping portion of the band. In the most contracted form, where the shield has the smallest inner diameter, the first end contacts the inner ridge and all of the inner abutment is either received within the receiving area or in contact with a corresponding outer abutment.

168, another shield 5000 is shown to illustrate another locking mechanism of the present invention, with like reference numerals being used to indicate like parts throughout. The first end 5010 has a protrusion 5034 sized and shaped to fit within a slot 5036 formed in the second end 5012. Abutting the protrusion 5034 against the slot 5036 creates a locking configuration and prevents further reduction in the inner diameter. As can be seen in FIG. 168, the slot 5036 is oriented substantially vertically, and the slot 5036 is curved to match the curvature of the shield band. Although one slot 5036 is shown, multiple slots 5036 can be provided to provide variability in the locking diameter.

169 and 170, another form of locking shield 5000 is shown. The shield 5000 has a first end 5010 configured to slide into a slot 5036 formed at the second end 5012. A plurality of slots 5036 are provided to provide variability in locking diameter. Each slot 5036 is substantially C-shaped forming a tongue 5038 behind which the first end 5010 is inserted to fix the inner diameter. The shield 5000 is unlocked by pulling apart the interlocking segments of the band to increase the diameter.

171, another form of shield having a locking mechanism is shown. The shield 5000 has one or more vertical slots 5036 formed at the second end 5012. The multiple slots 5036 are provided to provide the shield 5000 with variable locking positions. The first end 5010 has a protrusion 5034 with an outwardly extending hook 5040 that is sized and shaped to be received in any one of the slots 5036. The hook 5040 abuts the opening of the slot 5036 to limit the expansion or contraction of the inner diameter. The lock is released by deflecting the first end 5010 inwardly to remove the hook 5040 from the opening of the slot 5036.

172-174, another form of shield 5000 with a locking mechanism is shown. The shield 5000 has a first end 5010 with one or more holes 5042. The holes 5042 are provided to provide variable locking positions along the band to adjust the inner diameter and to lock the band in place as desired. The second end 5012 of the shield 5000 has a protrusion 5034. The protrusion 5034 has a circular head connected to a neck portion 5044. The protrusion 5034 extends radially inward from the inner surface 5002 of the band. Each hole 5042 has two portions. The first portion of the hole 5042 has an opening shaped to correspond to the head of the protrusion 5034 and sized to allow the head of the protrusion 5034 to fit into the hole 5042 as shown in FIG. As shown in FIG. 174, the projection 5034 is then moved into the second portion of the hole 5042, which forms a channel for the neck portion 5044 and forms a restraint for the head portion, so that when the projection 5034 is in the second portion of the hole 5042, the bed portion cannot be removed unless the head portion is aligned and threaded through the first portion of the hole 5042. The slot-lock secures the head portion of the projection 5034 at the second end 5012 into one of the holes 5042 along the first end 5010 to secure and lock the inner diameter and prevent the inner diameter from being increased or decreased in size.

175, another form of shield 5000 having a locking mechanism is shown. The lock has a protrusion 5034 extending outwardly from the outer surface 5004 near the first end 5010. The protrusion 5034 is vertically oriented. The second end 5012 has one or more correspondingly shaped vertically oriented slots 5036. The multiple slots 5036 are provided to provide variability in the size and adjustment of the inner diameter of the shield 5000. The first end 5010 is deflected inwardly to fit within the second end 5012, thereby spiraling the shield 5000 into a reduced inner diameter. Once the desired inner diameter is achieved for a particular surgical purpose, the protrusion 5034 is aligned with the desired slot 5036 to obtain the desired inner diameter, and the protrusion 5034 is inserted into the slot 5036. The projections 5034 abut the slots 5036 and prevent the shield 5000 from expanding or contracting in size and inner diameter, thereby locking the inner diameter of the shield 5000 in the desired configuration. To unlock the shield 5000, the projections 5034 are reversed and pushed back out of the slots 5036 by deflecting the first end 5010 inward or the second end 5012 outward to release the projections 5034 from the slots 5036. In the unlocked configuration, the size of the inner diameter can be reduced so that the shield can be easily withdrawn from the incision or body opening. The shield 5000 can be readjusted to have an increased or decreased inner diameter and relocked as desired while in the incision/opening.

176, another form of shield 5000 having a locking mechanism is shown. The lock has one or more projections 5034 extending outwardly from the inner surface 5002 near one of the first end 5010 and the second end 5012. The projections 5034 are horizontally oriented and perpendicular to the inner surface 5002 and/or the longitudinal axis. In FIG. 176, one projection 5034 is located near the top end 5006 and another projection (not shown) is located near the bottom end 5008. The second end 5012 has one or more correspondingly shaped horizontally oriented slots 5036 that are sized and shaped to receive the one or more projections 5034. A plurality of slots 5036 are provided along the circumference of the shield 5000, thereby providing variability in the size, inner diameter, and adjustment of the locking position of the shield 5000. The first end 5010 is deflected inwardly to fit within the second end 5012, thereby spiraling the shield 5000 into a smaller inner diameter. Once the desired inner diameter is achieved for a particular surgical objective, incision, orifice, or size of tissue to be excised, one or more protrusions 5034 are aligned with one or more corresponding slots 5036 to obtain the desired inner diameter. Each protrusion 5034 is inserted into a corresponding slot 5036. The protrusions 5034 abut the slots 5036 and prevent the shield 5000 from expanding or contracting in size and inner diameter, thereby locking the inner diameter of the shield 5000 in the desired configuration. The top end 5006 and bottom end 5008 are locked uniformly relative to one another. To unlock the shield 5000, the projection 5034 is pushed back out of the slot 5036 by deflecting the first end 5010 inward or the second end 5012 outward to release the projection 5034 from the slot 5036, thereby achieving an unlocked configuration. In the unlocked configuration, the size of the inner diameter can be reduced so that the shield can be easily withdrawn from the incision or body opening. The shield 5000 can be readjusted to have an increased or decreased inner diameter and relocked as desired while in the incision/opening.

177, another form of shield 5000 having a locking mechanism is shown. The lock has at least one abutment 5020 extending outwardly and perpendicularly from the inner surface 5002 near the second end 5012. The abutment 5020 extends between the top end 5006 and the bottom end 5008 in a vertically oriented configuration. A plurality of abutments 5020 are provided, each spaced apart from one another and from the second end 5012 to provide variability in the adjustment of the size and inner diameter of the shield 5000. The plurality of abutments 5020 form a stepped arrangement of a plurality of curved steps along the inner surface 5002, with the first end 5010 configured to abut against such steps. The first end 5010 is a curved edge corresponding to the curvature of the shield 5000. Any size and shape abutment can be provided with a correspondingly shaped abutment at one location, such as at the first end 5010 on the other side of the shield 5000, or at other locations along the inner or outer surface of the shield. The first end 5010 is deflected inward to fit within the second end 5012. The shield is spiraled into a small inner diameter. Once the desired inner diameter is achieved for a particular surgical purpose, the first end 5010 or the other abutment at or near the first end is aligned with and contacts one of the abutments 5020 at or near the other side or second end 5012 of the shield 5000. The contact between the first end 5010 and the abutment 5020 provides a lateral/diametric lock that prevents the shield from decreasing in size and its inner diameter. However, this locking configuration allows for expansion in the lateral/diametric dimension. When expansion occurs, the first end 5010 can be moved to contact and snap into the adjacent abutment 5020, thereby creating another locked position. To unlock, the first end 5010 can be moved out of contact with the abutment 5020, thereby allowing for variability in shield size. In the unlocked configuration, the size of the inner diameter can be reduced so that the shield can be easily withdrawn from the incision or body orifice. The shield 5000 can be readjusted so that it has an increased or decreased inner diameter, and the shield can be relocked as desired.

178, another form of shield 5000 having a locking mechanism is shown. The lock has at least one abutment 5020 extending outwardly and perpendicularly from the inner surface 5002 near the second end 5012. The abutment 5020 extends between the top end 5006 and the bottom end 5008 in a vertically oriented configuration. A plurality of abutments 5020 are provided, each spaced apart from one another and from the second end 5012 to provide variability in the adjustment of the size and inner diameter of the shield 5000. The plurality of abutments 5020 form a stepped arrangement of a plurality of curved steps along the inner surface 5002, with the first end 5010 configured to abut against such steps. The first end 5010 is a curved edge corresponding to the curvature of the shield 5000. Any size and shape of abutment can be provided with a correspondingly shaped abutment at one location, such as at the first end 5010 on the other side of the shield 5000, or at other locations along the inner or outer surface of the shield. The shield 5000 further includes one or more projections 5034 extending outwardly from the inner surface 5002 and disposed adjacent at least one abutment 5020. One projection 5034 is provided adjacent each abutment 5020. In the embodiment shown in FIG. 178, three abutments 5020 are shown with three projections 5034 positioned adjacent each abutment 5020. The projections 5034 are cylindrical in shape, but can be any shape. The abutments 5020 and projections 5034 are associated with the second end 5012 of the band. The band has one or more holes 5042 formed at or near the first end 5010. The holes 5042 are sized and shaped to receive the projections 5034 and are spaced apart from one another such that all of the projections 5034 are insertable into the corresponding holes 5042 in one diametrical arrangement of the shield 5000. The first end 5010 is deflected inwardly to fit within the second end 5012. The shield is spiraled to a small inner diameter. Once the desired inner diameter is achieved for a particular surgical purpose, the first end 5010 or the other abutment at or near the first end is aligned with and contacts one of the abutments 5020 at or near the other side or second end 5012 of the shield 5000. In doing so, the corresponding one or more projections 5034 are threaded through the corresponding holes 5042 to lock the shield in place. The contact of the first end 5010 with the abutment 5020 provides a lateral/diametric lock that prevents the size of the shield and its inner diameter from decreasing. The abutment of the projection 5034 against the hole 5042 further provides a lateral/diametric lock that prevents the size of the shield and its inner diameter from increasing as well as decreasing. To release the lock, one or more projections 5034 of the second end 5012 are moved out of contact with one or more holes 5020 of the first end 5042, and the first end 5010 is moved out of contact with the abutment 5020, thereby providing variability in the shield size. In the unlocked configuration, the size of the inner diameter can be reduced so that the shield can be easily withdrawn from the incision or body opening. Of course, the shield 5000 can be readjusted to have an increased or decreased inner diameter, and the shield can be relocked as desired.

179 and 180, the locking mechanism shield 5000 has a plurality of corrugations 5046 disposed about the band or at least near the first end 5010 and near the second end 5012. The configuration of FIG. 179 and FIG. 180 has the corrugations disposed all around the circumference of the shield 5000. The corrugations 5046 are vertically oriented folds that extend along the longitudinal axis. The folds form a plurality of peaks 5048 alternating with valleys 5050 all around the circumference of the shield 5000. The peaks 5048 project inwardly into the central lumen toward the longitudinal axis, and the valleys 5050 are disposed between the peaks 5048. The valleys 5050 project outwardly away from the longitudinal axis and away from the central lumen. The peaks 5048 and valleys 5050 are correspondingly shaped such that each peak 5048 is received or nested within each valley 5050 in an interlocking relationship. The peaks 5048 are formed by bends in the band. The corrugations 5046 are vertical folds or bellows that extend along the longitudinal axis. The corrugations 5046 facilitate a reduction in the diametric/lateral dimension of the shield 5000 by providing multiple hinge locations around the circumference. The peaks 5048 at the inner surface 5002 form valleys 5050 at the outer surface 5004. The first end 5010 or the second end 5012 is deflected inwardly to nest within the other of the first end 5010 or the second end 5012. The shield 5000 is spiraled into a small inner diameter. Once the desired inner diameter is achieved, one or more peaks 5048 are engaged into one or more valleys 5050 to create a locked configuration as shown in FIG. 180, in which the expansion or contraction of the lateral/diametric dimension of the shield 5000 is fixed. One or more peaks 5048 at the inner surface 5002 of the second end 5012 are engaged into one or more valleys 5050 at the outer surface 5004 of the first end 5010 in tangential, circumferential abutment. To release the lock, one or more peaks 5048 are withdrawn from abutment within one or more valleys 5050. In the unlocked configuration, the size of the inner diameter can be reduced so that the shield can be easily withdrawn from the incision or body orifice. Of course, the shield 5000 can be readjusted to have an increased or decreased inner diameter, and the shield can be relocked as desired.

181, an alternative embodiment of a shield 6000 is shown. The shield 6000 is made of a rigid material, such as plastic or metal, or other material. The shield 6000 has a first end 6002 interconnected with a second end 6004 between an outer periphery 6006 and an inner periphery 6008. The shield 6000 defines an inflection between the outer periphery 6006 and the inner periphery 6008, the inflection extending between the first end 6002 and the second end 6004. The inflection in FIG. 181 is curved, but the invention is not so limited. The shield 6000 has a flange 6010 with an upper surface 6012 opposite a lower surface 6014, defining a thickness between the upper and lower surfaces. The flange 6010 is substantially flat, which helps provide a cutting board-like surface for performing manual morcellation and protecting the surrounding tissue. The flange 6010 is interconnected with a depending portion 6016. The depending portion 6016 has an inner surface 6018 that is contiguous with the upper surface 6012 of the flange 6010. The depending portion 6016 has an outer surface 6020 that is contiguous with the lower surface 6014 of the flange 6010. The depending portion 6016 is curved. In one form, the arc defined between the first end 6002 and the second end 6004 is about 180° or less. In another form, the arc defined between the first end 6002 and the second end 6004 is about 45°-290°. The shield 6000 is configured such that the depending portion 6016 is insertable into an incision or into a mouth or other body opening to partially circumferentially retract tissue edges at the incision. The depending portion 6016 acts as a hook to secure the flange 6010 at the incision site and provide protection to the surrounding tissue. The shield 6000 is rigid and cut resistant so that the surgeon can safely morcellate against the flange 6010. The shield 6000 of FIG. 181 can be used by itself and can be inserted directly into the incision/orifice or can be used in combination with a retractor and/or storage bag, etc., as described herein. A two ring retractor is inserted into the incision site or orifice with webbing between them and the tissue edges are retracted by rolling them up to the apex ring, whereby the webbing is wrapped around the apex ring as described herein. After the incision/orifice is retracted, the shield 6000 is placed into the retractor, thereby protecting the surrounding tissue and the retractor webbing from accidental dissection during the morcellation procedure. The flange 6010 is wide enough to cover the outer tissue, e.g., abdominal wall, to provide a protective shelf/apron for the patient. Although the depending portion 6016 is shown curved, the invention is not so limited and the depending portion may be flat or C-shaped. The C-shaped depending portion may help hook the shield 6000 at the incision site. All of the methods described herein for the guards and/or shields may be utilized with all of the guards and shields described herein, including but not limited to use with or without a containment bag and/or retractor and/or other devices described herein or known to one of skill in the art.

As will be understood, various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the invention.

Claims (14)

1. A system for removing a tissue specimen through a body orifice defining a tissue margin, the system comprising:
a shield having a band made of a flexible cut-resistant material, the band having inner and outer surfaces connected to one another by top and bottom ends and first and second ends, the band configured to define a central lumen with a longitudinal axis, the central lumen having a lumen diameter perpendicular to the longitudinal axis;
the band has a plurality of corrugations along the shield, the corrugations being folds or bellows oriented with ridges extending vertically along the longitudinal axis to form a plurality of peaks alternating with a plurality of valleys along the shield;
the band, in a rest configuration, is split such that a gap is formed between the first and second ends, and the band transitions to a contracted configuration by flexing one of the first and second ends inwardly and nesting the one of the first and second ends within the other of the first and second ends to form a spiral with overlapping portions ;
the shield is configured to have a variable lumen diameter by varying the overlap portion;
one or more of the plurality of peaks are configured to nest within one or more of the plurality of valleys to define a locked configuration and fix the lumen diameter.
A system characterized by: The plurality of peaks project inwardly toward the longitudinal axis into the central lumen with the plurality of valleys interposed therebetween.
The system of claim 1 . the plurality of valleys projecting outwardly away from the longitudinal axis and the central lumen.
The system of claim 2. the plurality of peaks and valleys are correspondingly shaped such that each of the plurality of peaks is received or nested within one of the plurality of valleys;
The system of claim 1 . Each of the plurality of peaks defines a corresponding valley on the inner surface.
The system of claim 1 . The plurality of corrugated portions are formed around the entire circumference of the shield.
The system of claim 1 . the plurality of corrugations are formed adjacent the first and second ends;
The system of claim 1 . the plurality of corrugations function in conjunction with tissue pressure to achieve a locked configuration when inserted into the body orifice.
The system of claim 1 . In the locked configuration, the shield constricts the tissue margins when inserted into the body opening.
The system of claim 1 . the shield maintains the locked configuration only when disposed within the body opening and exposed to radial pressure on the shield by the tissue margin .
10. A system according to claim 8 or 9. the rest configuration defines a rest lumen diameter, and the bands have no overlapping portions when in the rest configuration and are configured to spring back from an increased or decreased diameter toward the rest configuration and the rest lumen diameter.
The system of claim 1 . an outer surface of the band having a recess extending circumferentially around the shield from the first end to the second end along the longitudinal axis from the top end to the bottom end ;
The system of claim 1 . The apical end has an apical flange extending radially outwardly to form a funnel-like shape with the lumen diameter increasing toward the apical end .
The system of claim 1 . the bottom end has a bottom flange extending radially outwardly to form a funnel-like shape with the lumen diameter increasing toward the bottom end;
The system of claim 13.

Images